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Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

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Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life
Business

Business

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

2024-10-04 18:45 Last Updated At:19:05

Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue

GALWAY, Ireland, Oct. 4, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMedâ„¢ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue. The FDA has classified this action as a class I recall.

Medtronic issued an updated notification to customers stating the following:

  • Even a single drop of the pump could result in reduced battery life, either immediately after the drop, or over time, and the issue will continue even after replacing the battery.
  • The pump will still generate battery alerts and alarms, but these alerts and alarms may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery. Be prepared to replace the battery as soon as the "Low Battery Pump" alarm sounds.
  • Users should always carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries should they need to replace the battery sooner than expected.
  • Users who notice a significant decrease in battery life from their usual experience, regardless of whether their pump has been dropped, bumped, or has experienced physical impact, should contact their local Medtronic team to determine whether a replacement pump is needed. Customers in the U.S. can call 1-800-378-2292 for 24-hour technical support. Customer outside the U.S. can click on this link to find the number for their local support team.
  • Users are advised to have a back-up therapy available in case it's needed.

''Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes," said Robert Vigersky, MD, Chief Medical Officer, Medtronic Diabetes. "Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump. Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed."  

The original notification and the updated notification are available on the Medtronic Diabetes website.

About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)  
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health. 

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 

Contacts:


Janet Cho                             

Ryan Weispfenning

Public Relations                   

Investor Relations

+1 (818) 403-7028               

+1 (763) 505-4626







Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue

GALWAY, Ireland, Oct. 4, 2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMedâ„¢ 600 series or 700 series insulin pumps to follow their pump's built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue. The FDA has classified this action as a class I recall.

Medtronic issued an updated notification to customers stating the following:

  • Even a single drop of the pump could result in reduced battery life, either immediately after the drop, or over time, and the issue will continue even after replacing the battery.
  • The pump will still generate battery alerts and alarms, but these alerts and alarms may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery. Be prepared to replace the battery as soon as the "Low Battery Pump" alarm sounds.
  • Users should always carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries should they need to replace the battery sooner than expected.
  • Users who notice a significant decrease in battery life from their usual experience, regardless of whether their pump has been dropped, bumped, or has experienced physical impact, should contact their local Medtronic team to determine whether a replacement pump is needed. Customers in the U.S. can call 1-800-378-2292 for 24-hour technical support. Customer outside the U.S. can click on this link to find the number for their local support team.
  • Users are advised to have a back-up therapy available in case it's needed.

''Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes," said Robert Vigersky, MD, Chief Medical Officer, Medtronic Diabetes. "Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump. Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed."  

The original notification and the updated notification are available on the Medtronic Diabetes website.

About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)  
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health. 

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. 

Contacts:

Janet Cho                             

Ryan Weispfenning

Public Relations                   

Investor Relations

+1 (818) 403-7028               

+1 (763) 505-4626

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life

LAS VEGAS, Jan. 12, 2026 /PRNewswire/ -- Roborock, the global leader in home robotics engineered to simplify daily life, became the most awarded Robotic Vacuum Brand at CES 2026, after announcing its new product line-up for the first half of the year. Under the theme "The Greatest Meeting the Greatest", the brand's keynote presentation led by Roborock's President, Quan Gang, unveiled the Saros Rover, the world's first robotic vacuum with AI-powered wheel-leg architecture that can both navigate stairs and slopes with human-like agility while cleaning them.

Announcements also included the Roborock Saros 20, Roborock Saros 20 Sonic, Roborock F25 ACE Pro, and Roborock Qrevo Curv 2 Flow. These launches happened in partnership with Real Madrid Football Club for the Vacuum Cleaner category, announced ahead of the show's starting date.

Roborock also announced separate to the Real Madrid partnership its entry into the US market for lawnmower products, including the new RockMow X1 LiDAR. Consumers, clients, and interested parties can visit Roborock's Booth #52632 at Venetian Expo CES 2026 from January 6 to January 9th during show hours.

Roborock Saros Rover - The World's First Wheel-Leg Robovac

In a world-first, Roborock introduced at CES 2026 the Roborock Saros Rover, featuring the world's first two-wheel-leg architecture in a robovac. Each wheel-leg provides reach, lift, height, and imitates human mobility, enabling the robot to raise and lower each one of the wheel-legs independently, execute small jumps, agile turns, sudden stops, and directional changes, all while maintaining a level body as the ground changes.

At a software level, Saros Rover harnesses the power of Artificial Intelligence algorithms, in conjunction with complex motion sensors and 3D spatial information to understand its environment and make its wheel-legs react with precision.

The Saros Rover excels in multi-storey homes, where it is able to clean each one of the steps of a staircase as it goes to the second floor, dramatically reducing "no-go" zones and transitioning into cleaning areas previously inaccessible for homes with a single robovac.

The Saros Rover is able to tackle several types of non-flat surfaces, with staircases being the most obvious one. This includes not only traditional staircases but also curved staircases, or even carpeted staircases with bullnose fronts, all while cleaning each one of their steps as it navigates through them. Other types of surfaces that Saros Rover is able to tackle include slopes as well as complex multi-level room thresholds requiring height and power.  Saros Rover is a real product in development with an unconfirmed launch date.

The Greatest Meeting The Greatest - Roborock and Real Madrid Football Club join hands

Announced days before the show's beginning, Roborock presents at CES its first activation within the strategic global partnership with Real Madrid Football Club's First Men and First Women teams, widely ranked as one of the greatest football clubs in history. The partnership is solely related to Roborock's extensive portfolio of Vacuum Cleaner products and excludes other product lines from the brand. Under the umbrella theme of "The Greatest Meeting The Greatest", the partnership responds to a deep affinity between the brand ethos of both organizations, which have achieved remarkable historical performance with innovation as common denominator. The partnership will bring Roborock's smart-cleaning innovations to life through stadium exposure, campaigns and player-led storytelling that translate the meaning of "Real Smart Cleaning" from the pitch to the home.

Roborock's early 2026 Robovac line-up: Roborock Saros 20, Roborock Saros 20 Sonic, and Roborock Qrevo Curv 2 Flow

At its keynote, Clarbi Lu, product marketing lead at Roborock, unveiled new smart cleaning products launching in the first half of the year. Leading the lineup are the Roborock Saros 20 and Roborock Saros 20 Sonic, the latest flagship models in the Saros Series. Saros 20 upgrades the StarSight™ Autonomous System 2.0 with enhanced AI object recognition and a new AdaptiLift Chassis 3.0 for improved threshold climbing. Saros 20 Sonic adds RetractSense™ Navigation, an ultra-slim body, and the VibraRise® 5.0 Mopping System. Both use a 35,000 Pa HyperForce® motor and a new RockDock®. The Qrevo Series also expands with the Roborock Qrevo Curv 2 Flow.

Rockmow X1 LiDAR, X1, RockNeo Q1 lead the Roborock North American Roll-Out of Lawnmowers

Roborock has announced its North American expansion into the lawnmower category with three key models. The flagship RockMow X1 LiDAR features Sentisphere™ LiDAR Environmental Perception, 4WD traction, and Active Steering for flawless coverage. Alternatively, the RockMow X1 utilizes RTK and VSLAM navigation alongside a Dynamic Suspension System for industry-leading edge cutting. For smaller gardens, the entry-level RockNeo Q1 makes smart care accessible by combining RTK + VSLAM navigation with Stereo Vision Obstacle Avoidance.

For pricing and availiability, please contact your local Roborock sales or communications representative.

About Roborock

Roborock is a leading smart cleaning brand renowned for its intelligent cleaning solutions. Having become the #1 best-selling robotic vacuum cleaner brand according to IDC*, Roborock enriches lives with its innovative line of robotic, cordless, wet/dry vacuum cleaners, robotic lawn mowers and washer-dryers. Rooted in a user-centric approach, our R&D-driven solutions cater to diverse cleaning needs in millions of homes across more than 170 countries and regions. Headquartered in Beijing and with strategic subsidiaries in key markets, including the United States, Japan, the Netherlands, Poland, Germany, and South Korea, Roborock is dedicated to elevating its market presence worldwide. As of 2026, Roborock serves more than 22 million households. For more information, visit https://global.roborock.com/.

LAS VEGAS, Jan. 12, 2026 /PRNewswire/ -- Roborock, the global leader in home robotics engineered to simplify daily life, became the most awarded Robotic Vacuum Brand at CES 2026, after announcing its new product line-up for the first half of the year. Under the theme "The Greatest Meeting the Greatest", the brand's keynote presentation led by Roborock's President, Quan Gang, unveiled the Saros Rover, the world's first robotic vacuum with AI-powered wheel-leg architecture that can both navigate stairs and slopes with human-like agility while cleaning them.

Announcements also included the Roborock Saros 20, Roborock Saros 20 Sonic, Roborock F25 ACE Pro, and Roborock Qrevo Curv 2 Flow. These launches happened in partnership with Real Madrid Football Club for the Vacuum Cleaner category, announced ahead of the show's starting date.

Roborock also announced separate to the Real Madrid partnership its entry into the US market for lawnmower products, including the new RockMow X1 LiDAR. Consumers, clients, and interested parties can visit Roborock's Booth #52632 at Venetian Expo CES 2026 from January 6 to January 9th during show hours.

Roborock Saros Rover - The World's First Wheel-Leg Robovac

In a world-first, Roborock introduced at CES 2026 the Roborock Saros Rover, featuring the world's first two-wheel-leg architecture in a robovac. Each wheel-leg provides reach, lift, height, and imitates human mobility, enabling the robot to raise and lower each one of the wheel-legs independently, execute small jumps, agile turns, sudden stops, and directional changes, all while maintaining a level body as the ground changes.

At a software level, Saros Rover harnesses the power of Artificial Intelligence algorithms, in conjunction with complex motion sensors and 3D spatial information to understand its environment and make its wheel-legs react with precision.

The Saros Rover excels in multi-storey homes, where it is able to clean each one of the steps of a staircase as it goes to the second floor, dramatically reducing "no-go" zones and transitioning into cleaning areas previously inaccessible for homes with a single robovac.

The Saros Rover is able to tackle several types of non-flat surfaces, with staircases being the most obvious one. This includes not only traditional staircases but also curved staircases, or even carpeted staircases with bullnose fronts, all while cleaning each one of their steps as it navigates through them. Other types of surfaces that Saros Rover is able to tackle include slopes as well as complex multi-level room thresholds requiring height and power.  Saros Rover is a real product in development with an unconfirmed launch date.

The Greatest Meeting The Greatest - Roborock and Real Madrid Football Club join hands

Announced days before the show's beginning, Roborock presents at CES its first activation within the strategic global partnership with Real Madrid Football Club's First Men and First Women teams, widely ranked as one of the greatest football clubs in history. The partnership is solely related to Roborock's extensive portfolio of Vacuum Cleaner products and excludes other product lines from the brand. Under the umbrella theme of "The Greatest Meeting The Greatest", the partnership responds to a deep affinity between the brand ethos of both organizations, which have achieved remarkable historical performance with innovation as common denominator. The partnership will bring Roborock's smart-cleaning innovations to life through stadium exposure, campaigns and player-led storytelling that translate the meaning of "Real Smart Cleaning" from the pitch to the home.

Roborock's early 2026 Robovac line-up: Roborock Saros 20, Roborock Saros 20 Sonic, and Roborock Qrevo Curv 2 Flow

At its keynote, Clarbi Lu, product marketing lead at Roborock, unveiled new smart cleaning products launching in the first half of the year. Leading the lineup are the Roborock Saros 20 and Roborock Saros 20 Sonic, the latest flagship models in the Saros Series. Saros 20 upgrades the StarSight™ Autonomous System 2.0 with enhanced AI object recognition and a new AdaptiLift Chassis 3.0 for improved threshold climbing. Saros 20 Sonic adds RetractSense™ Navigation, an ultra-slim body, and the VibraRise® 5.0 Mopping System. Both use a 35,000 Pa HyperForce® motor and a new RockDock®. The Qrevo Series also expands with the Roborock Qrevo Curv 2 Flow.

Rockmow X1 LiDAR, X1, RockNeo Q1 lead the Roborock North American Roll-Out of Lawnmowers

Roborock has announced its North American expansion into the lawnmower category with three key models. The flagship RockMow X1 LiDAR features Sentisphere™ LiDAR Environmental Perception, 4WD traction, and Active Steering for flawless coverage. Alternatively, the RockMow X1 utilizes RTK and VSLAM navigation alongside a Dynamic Suspension System for industry-leading edge cutting. For smaller gardens, the entry-level RockNeo Q1 makes smart care accessible by combining RTK + VSLAM navigation with Stereo Vision Obstacle Avoidance.

For pricing and availiability, please contact your local Roborock sales or communications representative.

About Roborock

Roborock is a leading smart cleaning brand renowned for its intelligent cleaning solutions. Having become the #1 best-selling robotic vacuum cleaner brand according to IDC*, Roborock enriches lives with its innovative line of robotic, cordless, wet/dry vacuum cleaners, robotic lawn mowers and washer-dryers. Rooted in a user-centric approach, our R&D-driven solutions cater to diverse cleaning needs in millions of homes across more than 170 countries and regions. Headquartered in Beijing and with strategic subsidiaries in key markets, including the United States, Japan, the Netherlands, Poland, Germany, and South Korea, Roborock is dedicated to elevating its market presence worldwide. As of 2026, Roborock serves more than 22 million households. For more information, visit https://global.roborock.com/.

** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

CES 2026: Roborock releases the world's first robotic vacuum with wheel-leg architecture as it joins hands with Real Madrid Football Club

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