25 results

• Leadless Pacemakers May Have Lower Complications Rates: Study

  October 20, 2021

  Russell Maas

  The findings of a new study indicate leadless pacemakers have a lower rate of complications than older implants which require wired leads be implanted in the heart.

• St. Jude Settles Justice Dept Charges Over ICD Battery Problems With $27M Payment

  July 20, 2021

  Irvin Jackson

  St. Jude will pay the Justice Department $27 million to settle a whistleblower claim that it lied to the FDA about the safety of several of its implantable defibrillators, which resulted in patient deaths and a recall.

• Abandoned Defibrillator Leads Will Not Interfere With MRIs: Study

  March 1, 2021

  Russell Maas

  A new study suggests patients with abandoned, often defective, implanted defibrillator leads are safe to undergo MRI scans.

• 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 Defibrillator Battery Settlement Resolves Class Action Lawsuit in Canada

  August 8, 2019

  Austin Kirk

  A class action lawsuit over battery problems with St. Jude ICDs has resulted in a $5 million settlement in Canada.

• St. Jude ICD, CRT-D Recall Addresses Battery Problems and Cybersecurity Risks

  April 18, 2018

  Irvin Jackson

  The FDA has approved a new update to address battery problems linked to Abbott Laboratories (formerly St. Jude) ICD and CRT-D heart implants.

• St. Jude Defibrillator Battery Failure Recall Updated To Announce New Battery Monitoring Software

  October 26, 2017

  Irvin Jackson

  The FDA has announced that St. Jude has released new software meant to provide earlier warning of possible battery failure in recalled defibrillator implants.

• St. Jude Defibrillator Battery Class Action Lawsuit Filed Over Delay in Announcing Recall

  September 25, 2017

  Irvin Jackson

  A class action lawsuit against St. Jude and Abbott Laboratories accuses the companies of knowingly selling defective defibrillators with batteries that could rapidly fail, costing insurers millions of dollars.

• St. Jude Pacemaker Recall Issued To Fix Hacking Risk

  August 31, 2017

  Russell Maas

  Federal health officials have issued a recall for nearly 500,000 St. Jude pacemakers to fix cybersecurity vulnerabilities, which may allow...

• Recalled St. Jude Defibrillators With Bad Batteries Continued to be Implanted in Patients: FDA

  April 19, 2017

  Irvin Jackson

  The FDA has issued a warning letter to St. Jude and its parent company, Abbott, indicating that they continued to ship out defective defibrillators after an October 2016 recall, resulting in seven patients being implanted with devices with batteries that could suddenly fail.