19 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.

• 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.

• Sprint Fidelis Lead Failure Could Be Due To Generator Replacement: Study

  July 23, 2012

  Ricky Allen

  According to a study published earlier this year, there appears to be a connection between the exchange of implantable cardioverter-defibrillator...

• Medical Device Identification System Proposed by FDA

  July 5, 2012

  Irvin Jackson

  A new tracking system proposed by federal health regulators aims to quickly identify problems with medical devices once they are...

• Boston Scientific Defibrillators May Have Deadly Defect: Report

  April 25, 2012

  Irvin Jackson

  Another major internal defibrillator may have a flaw that could be responsible for at least one death. 

• Medical Device Companies Fight FDA Safety Improvements: Report

  February 28, 2012

  Staff Writers

  A recent report by the consumer watchdog group Public Citizen suggests that medical device companies have employed a small army...

• Heart Defibrillators Often Implanted in Inappropriate Patients: Study

  January 5, 2011

  Staff Writers

  More than one out of every five heart defibrillators implanted in the United States may be unnecessary, or were implanted...

• Medtronic Sprint Fidelis Lead Failure Rates Reportedly As High As 9.2%

  February 8, 2010

  Staff Writers

  According to new research, the failure rate for recalled Medtronic Sprint Fidelis leads, which are small wires used to connect...

• Medtronic Sprint Fidelis Lead Failures Could Hit 30% in Four Years

  January 5, 2010

  AboutLawsuits

  A new analysis by UBS Investment Research warns that the failure rate for Medtronic Sprint Fidelis defibrillator leads could reach...