122 results

• Boston Scientific Spinal Cord Stimulator Lawsuit Claims Lead and Battery Problems Led to Multiple Revision Surgeries

  October 22, 2025

  Michael Adams

  Boston Scientific and the U.S. Food and Drug Administration (FDA) are facing a lawsuit over an allegedly defective spinal cord stimulator, which claims both the manufacturer and the agency failed to ensure that newer versions of the implant were properly tested for safety and effectiveness.

• Accolade Pacemaker Recall Issued by Boston Scientific Due to Life-Threatening Injury Risks

  October 14, 2025

  Darian Hauf

  More than 55,000 Accolade and Accolade Proponent pacemakers are being recalled after federal regulators warned that a battery defect may cause the devices to suddenly enter Safety Mode, putting patients at serious risk.

• Boston Scientific Watchman and Defibrillation Devices Linked to Hundreds of Injuries, Dozens of Deaths

  August 7, 2025

  Darian Hauf

  Federal safety officials have issued warnings for the Boston Scientific Watchman Access System and defibrillator leads, which have been linked to more than 500 injuries and 33 deaths.

• Medical Device Manufacturers Often Fail To Submit Timely Adverse Event Reports to FDA: Study

  March 19, 2025

  Martha Garcia

  The findings of a new study indicate that medical device manufacturers turn in a third of all adverse patient event reports later than legally required.

• Boston Scientific Pacemaker Recall Comes After Hundreds of Injuries, Two Deaths Reported

  February 24, 2025

  Martha Garcia

  The FDA warns that battery problems with recalled Boston Scientific Accolade pacemakers puts patients at serious risk of death, with more than 800 injuries and at least two fatalities reported so far.

• Boston Scientific POLARx Balloon Catheter Use Instructions Updated After 4 Deaths: FDA

  December 19, 2024

  Darian Hauf

  Outdated use instructions for Boston Scientific POLARx and POLARx FIT cryoablation balloon catheters have led to a higher than anticipated number of injuries following procedures.

• Boston Scientific Accolade Pacemaker Recall Issued Due to Early Failure Risks

  December 17, 2024

  Martha Garcia

  The FDA has issued a safety warning, indicating power problems with certain Boston Scientific pacemakers constitute a recall and a potential danger to implant recipients.

• Obsidio Conformable Embolic Recall Issued After Reports of Deaths, Serious Injuries

  April 18, 2024

  Grace Muller

  Certain uses of Boston Scientific's Obsidio Conformable Embolic can lead to restrictive blood flow to organs, resulting in severe injuries and deaths, the FDA warns.

• Subcutaneous ICDs Linked to Less Complications with Leads, But May Cause More Unnecessary Shocks: Study

  November 22, 2022

  Martha Garcia

  The findings of a new study like subcutaneous ICDs to less risk of complications than more traditional ICDs.

• Boston Scientific Faces Vaginal Mesh Lawsuit Alleging Obtryx II Exposed Patients to Unreasonable Risk of Problems

  May 10, 2022

  Irvin Jackson

  A Boston Scientific vaginal mesh lawsuit claims the Obtryx II mesh is defectively designed, leading to unreasonable health risks for patients.