128 results

• 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.

• Vici Venous Stent Recall Follows Reports of Stent Migration

  May 24, 2021

  Martha Garcia

  Nearly 32,000 stents use to prevent blockages in the veins are being recalled due to the risk of migration and patient injury.

• Boston Scientific Mesh Settlement Results in $189M Payments to Resolve State Attorneys General Lawsuit

  March 24, 2021

  Irvin Jackson

  Boston Scientific will pay $187 million to resolve claims by most states that it misled both women and state health agencies over the safety and efficacy of transvaginal mesh products.

• Boston Scientific S-ICD Defibrillator Electrode Recall Due To Fracture Risk

  February 12, 2021

  Russell Maas

  Boston Scientific is recalling tens of thousands of ICD electrodes which may fail to deliver life-saving shocks to patients with ICDs, and have already been linked to serious injuries and deaths.

• Boston Scientific Recalls and Discontinues Lotus Edge Aortic Valve System For TAVR Surgeries

  January 12, 2021

  Irvin Jackson

  Boston Scientific is recalling and removing its Lotus Edge TAVR system from the market due to problems with the complexity of the delivery system.

• Boston Scientific Catheter Recall Issued Over Tip Detachment Risks

  April 8, 2020

  Russell Maas

  The FDA warns that certain Boston Scientific catheter tips could break off inside of patients' blood vessels, putting them at risk of serious injury or death.

• First Fully Disposable Duodenoscope Approved By FDA

  December 16, 2019

  Irvin Jackson

  The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.

• Boston Scientific Mesh Lawsuit Filed After FDA Forces Recall for Remaining Products on Market

  June 21, 2019

  Irvin Jackson

  A vaginal mesh lawsuit indicates Boston Scientific mesh devices caused severe injuries, complications and the need for surgery.

• Transvaginal Mesh Removed From Market Following Years of Lawsuits, Thousands of Devastating Problems

  April 17, 2019

  Irvin Jackson

  The FDA has banned the sale and distribution of transvaginal mesh products in the United States, saying they cannot guarantee the devices are safe or effective for women.