119 results

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  Outdated use instructions for Boston Scientific POLARx and POLARx FIT cryoablation balloon catheters have led to a higher than anticipated number of injuries following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

• Complications with Left Atrial Appendage Occlusion (LAAO) Devices More Likely Among Women Than Men, FDA Warns

  September 28, 2021

  Russell Maas

  The FDA is warning that a form of heart surgery used to treat atrial fibrillation appears to carry greater health risks for women than men.

• FDA Releases Final Result of Boston Scientific Transvaginal Mesh Studies

  August 17, 2021

  Irvin Jackson

  New postmarketing surveillance studies show Boston Scientific transvaginal mesh increase the risk of health complications for pelvic organ prolapse patients, without adding any additional effectiveness or safety over traditional surgical solutions.

• Ingenio Pacemaker, CRT-P Recall Issued After Dozens of Incidents and Patient Injuries

  August 9, 2021

  Russell Maas

  About 48,000 Boston Scientific Ingenio pacemakers and CRT-Ps are being recalled due to a malfunction which could put them into "safety mode", preventing life-saving corrections to patients' heart rhythm.