56 results

• 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.

• One-Third Of Patients With Recalled Internal Defibrillator Leads Suffered Significant Problems: Study

  January 8, 2020

  Irvin Jackson

  A new study reveals that about a third of patients who were left with defective, recalled St. Jude Riata leads suffered lead failures after being told they did not need to be removed.

• 1.1M Medical Device Reports Involving Problems Staplers, Defibrillators and Other Products Hidden From Public: Report

  May 22, 2019

  Irvin Jackson

  A new report reveals the FDA has allowed manufacturers to hide more than a million reports of serious injury and medical device malfunction away from public view since 2016.

• St. Jude Defibrillator Lawsuit Alleges Device Failure Resulted in Fatal Auto Accident

  October 5, 2017

  Irvin Jackson

  A wrongful death lawsuit filed against St. Jude says that its Riata defibrillator leads failed to respond to a man's heart rhythm problems, resulting in a fatal accident.

• St. Jude Optisure Defibrillator Lead Recall Issued Over Insulation Problems

  January 26, 2016

  Irvin Jackson

  A St. Jude Optisure defibrillator lead recall has been announced for hundreds of leads that may have insulation defects due to manufacturing problems.

• St. Jude Riata Settlement Reached for $64M over Recalled Defibrillator Leads

  March 2, 2015

  Irvin Jackson

  St. Jude is reporting that it has agreed to settle virtually all patient and shareholder lawsuits over defective Riata leads for more than $64 million.

• St. Jude Riata Lead Externalizations, Failures Worsen Over Time: Study

  July 22, 2014

  Irvin Jackson

  Danish researchers say St. Jude Riata lead problems are worsening and are recommending some patients risk heart surgery to get the defective leads replaced.

• Preemption Motion Granted in Part in St. Jude Riata Lead Lawsuits

  July 14, 2014

  Irvin Jackson

  A federal judge in Minnesota has dismissed a number of claims in a group of St. Jude Riata lawsuits, saying they were preempted by federal law.

• St. Jude Defibrillator Lead Factory Problems Resolved, Per FDA

  July 3, 2014

  Irvin Jackson

  The problems that led to a freeze on new medical devices at a St. Jude manufacturing facility have been fixed, according to the company.

• St. Jude Riata Lawsuit Scheduled for Trial in Feb. 2015

  March 20, 2014

  Austin Kirk

  A joint bellwether trial of two St. Jude Riata lead lawsuits is scheduled for February of next year.