US EditionFDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
UNITED STATES, AUG 6 – The FDA reported 506 serious injuries and 33 deaths linked to Boston Scientific's defibrillator leads and Watchman heart implant, prompting alerts to healthcare providers.
- On August 6, 2025, the FDA cautioned that Boston Scientific heart devices may cause injuries or deaths due to electrical problems in defibrillators and air embolisms during implant procedures.
- The risk of air embolism is acute and limited to the implant procedure; Boston Scientific’s Endotak Reliance wires were distributed from 2002 to 2021 and are now discontinued.
- By July 30, 2025, Boston Scientific reported 120 serious injuries and 17 deaths related to heart devices, which account for two-thirds of its $5 billion quarterly revenue.
- Sending letters on July 24 and July 30, Boston Scientific advised physicians to review follow-up procedures and weigh device removal risks for patients.
- As the FDA continues its review, distributors should forward the notice to their customers and consumers are advised to check the FDA’s webpage for updates.
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The Food and Drug Administration (FDA) said on Wednesday it is monitoring a potential safety issue involving Boston Scientific Corporation’s (NYSE:BSX) ENDOTAK RELIANCE defibrillation leads, following a letter from the company alerting healthcare providers of possible reduced shock efficacy. Boston Scientific’s ENDOTAK RELIANCE leads are used with implantable cardioverter-defibrillators (ICDs) to deliver pacing and shock therapy to prevent sudde…
Associated Press News
FDA flags problems with two Boston Scientific heart devices tied to injuries and deaths
U.S. health officials have issued warnings on two separate Boston Scientific heart devices recently linked to injuries and deaths.
Air Embolism Deaths Tied to Watchman LAA Closure Device Access Systems
(MedPage Today) — More special care is needed when using the Watchman access systems used to deliver transcatheter left atrial appendage (LAA) closure devices due to a risk for air embolisms, according to an FDA alert. Instructions for use have… Source link : https://www.medpagetoday.com/cardiology/interventionalcardiology/116865 Author : Publish date : 2025-08-06 20:20:00 Copyright for syndicated content […] The post Air Embolism Deaths Tied to…
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