WASHINGTON (AP) — U.S. health regulators are warning doctors and patients about safety issues with two separate Boston Scientific heart devices recently linked to injuries and deaths.
The Food and Drug Administration issued two alerts Wednesday about electrical problems tied to the company's heart-zapping defibrillator systems and a separate issue with a heart implant used to reduce stroke risk.
The agency said some of the company's Endotak Reliance defibrillator wires can become calcified, leading to failures in delivering life-saving shocks to the heart, according to the FDA.
Defibrillators are surgically placed in the upper chest, where they monitor irregular heartbeats and use electrical shocks to jolt the heart back to normal.
As of July 24, Boston Scientific has reported 386 serious injuries and 16 deaths associated with this issue, the agency said.
Ten of the deaths were judged to be due to the device failing to function properly, the company said in an email. Four were linked to attempts to surgically remove the devices from patients and two others were deemed unrelated to the implants.
Boston Scientific's wires were distributed between 2002 and 2021 and are no longer available, the company noted in its letter to doctors. Some patients will need to have the devices replaced, though physicians should weigh the risks of the removal procedure.
In a separate notice, the FDA said Boston Scientific recently updated instructions for implanting its Watchman device, which closes a portion of the heart's left atrium to reduce the risk of stroke.
In a letter to physicians, the company noted that there is an increased risk of blockages in the bloodstream depending on the level of anesthesia for patients undergoing the initial implantation procedure. Watchman is an alternative to long-term treatment with blood thinners for patients at increased risk of stroke.
As of July 30, the company has reported 120 serious injuries and 17 deaths related to the issue, the FDA said.
A company investigation concluded that the safety issue “is not associated with the design or manufacture of any component of the Watchman system.
Heart devices, including defibrillators and other implants, are Boston Scientific’s largest business, making up two-thirds of its $5 billion in revenue for the most recent quarter.
Shares of Boston Scientific Corp. fell nearly 1.8 percent Wednesday to close at $102.95 in trading.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
FILE - The Boston Scientific logo is seen at company offices in Fremont, Calif., Feb. 1, 2017. (AP Photo/Marcio Jose Sanchez, File)
SYDNEY (AP) — A father and son are suspected by officials to have killed 15 people on a popular Australian beach, shocking a country where gun violence is rare. The government on Monday, a day after the shootings, proposed tougher new gun laws amid criticism that officials didn't take seriously enough a string of antisemitic attacks.
Here's a look at what to know from the attack at Bondi Beach:
Little is known about the suspects in the attack on Sydney's famous Bondi Beach, but there was widespread shock when officials said that the two men pictured firing weapons in social media videos were related.
The 50-year-old father, who was killed, arrived in Australia in 1998 on a student visa, authorities said, and was an Australian resident when he died. Officials wouldn’t confirm what country he had migrated from.
His 24-year-old Australian-born son, who was shot and wounded, is being treated at a hospital
The target was a Hanukkah celebration where hundreds had gathered to celebrate the first day of the eight-day Jewish holiday. Prime Minister Anthony Albanese called it an act of antisemitic terrorism.
Albanese said that Australia’s main domestic spy agency, the Australian Security Intelligence Agency, had investigated the son for six months in 2019. The Australian Broadcasting Corp. reported that the agency had examined the son’s ties to a Sydney-based Islamic State group cell. Albanese did not describe the associates, but said the spy agency was interested in them rather than the son.
The dead included a 10-year-old girl, a rabbi and a Holocaust survivor. Dozens of others were injured, some seriously.
Police said the father held a firearms license and that he was a member of a gun club, which suggests he was a target shooter.
One dramatic clip broadcast on Australian television showed a man appearing to tackle and disarm one of the gunmen, before pointing the man’s weapon at him, then setting the gun on the ground.
The man was identified by Home Affairs Minister Tony Burke as Ahmed al Ahmed. The 42-year-old fruit shop owner and father of two was shot in the shoulder by the other gunman and survived.
A wave of antisemitic attacks have shocked and angered many in Australia over the last year.
Australia has 28 million people and about 117,000 Jews.
Antisemitic incidents, including assaults, vandalism, threats and intimidation, surged more than threefold in the country during the year after Hamas attacked Israel on Oct. 7, 2023, and Israel launched a war on Hamas in Gaza in response, the government’s Special Envoy to Combat Antisemitism Jillian Segal reported in July.
Last year, there were antisemitic attacks in Sydney and Melbourne. Synagogues and cars have been torched, businesses and homes vandalized with graffiti, and Jews attacked in cities where 85% of the nation’s Jewish population lives.
Albanese in August blamed Iran for two of the attacks and cut diplomatic ties to Tehran.
Israel urged Australia’s government to address crimes targeting Jews. Prime Minister Benjamin Netanyahu said he warned Australia’s leaders months ago about the dangers of failing to take action against antisemitism. He claimed Australia’s decision — in line with scores of other countries — to recognize a Palestinian state “pours fuel on the antisemitic fire.”
Australia has strict gun control laws.
Mass shootings are extremely rare. A 1996 massacre in the Tasmanian town of Port Arthur, where a lone gunman killed 35 people, prompted the government to drastically tighten gun laws, making it much more difficult to acquire firearms.
Significant mass shootings this century included two murder-suicides with death tolls of five people in 2014 and seven in 2018, in which gunmen killed their own families and themselves.
In 2022, six people were killed in a shootout between police and Christian extremists at a rural property in Queensland state.
The prime minister said he was pushing for tougher gun laws.
People leave notes at a flower tribute for shooting victims outside the Bondi Pavilion at Sydney's Bondi Beach, Monday, Dec. 15, 2025, a day after a shooting. (AP Photo/Mark Baker)
New South Wales Premier Chris Minns, right, and Kellie Sloane, leader of the opposition, the New South Wales Liberal Party, lay wreaths at a tribute for shooting victims outside the Bondi Pavilion at Sydney's Bondi Beach, Monday, Dec. 15, 2025, a day after a shooting. (AP Photo/Mark Baker)
