12 results

• FDA Urges Doctors to “Transition Away” from Certain Getinge Heart Pumps Due to Ongoing Safety Issues

  May 15, 2024

  Martha Garcia

  The FDA is recommending health care professionals "transition away" from using certain Getinge heart devices due to ongoing reports of patient injuries and deaths.

• 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.

• Philips CPAP Masks Recalled Due to Risk Magnets May Interfere with Implants, Causing Serious Injury or Death

  September 7, 2022

  Russell Maas

  More than 17 million Philips CPAP masks are being recalled due to the risk of magnets interfering with medical implants.

• Pediatric Heart Devices Often Approved By FDA Without Clinical Trials Involving Children: Study

  August 15, 2022

  Irvin Jackson

  A new study finds that many children's heart implants are approved without researchers actually knowing the effect of those devices on children's bodies.

• Infected Heart Implants Often Left In Place, Despite Risks: Study

  April 13, 2022

  Martha Garcia

  Many patients with heart implant infections choose antibiotics over device removal, despite the higher risk of death, according to the findings of a new study.

• Airpods, Apple Pencil and Other Tech Devices Interfere with Heart Implants, Study Warns

  March 7, 2022

  Randy Dixon, Jr.

  A new study warns that some electronic devices can interfere with the functions of heart implants like pacemakers or defibrillators.

• 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.

• Pacemaker and Implantable Defibrillator Complication Rates Appear Hospital-Specific, Study Finds

  August 7, 2019

  Martha Garcia

  A new study finds that the hospital itself may be a determining factor in whether heart implant patients suffer complications.

• Medtronic Dual Chamber Implantable Pulse Generator Recall Issued Over Heart Pacing Problems

  February 19, 2019

  Martha Garcia

  The FDA warns that recalled Medtronic heart implants known as implantable pulse generators could stop working due to a circuit error, resulting in serious injury or death.

• FDA Approves High-Risk Heart Devices On Scant Scientific Evidence: Study

  September 5, 2018

  Martha Garcia

  A new study highlights concerns with the FDA's approval process for high-risk medical devices, pointing out more than a dozen times heart devices were recalled following approval over the last several years.