20 results

• Another Medtronic HVAD Recall: Driveline Cover May Stick, Delaying Vital Patient Care

  December 2, 2022

  Irvin Jackson

  A Medtronic HVAD recall warns that a driveline cover may become hard and difficult to remove, potentially delaying critical care for heart transplant patients.

• New Recommendations on Use of Medtronic HVAD Heart Systems Issued For Patients With The Implant

  November 18, 2022

  Irvin Jackson

  The FDA's new recommendations for recalled Medtronic HVAD systems indicate they should not be removed unless medically necessary.

• Medtronic Offers Hospitals Backup Controllers to Help Prevent HVAD Failures

  October 19, 2022

  Irvin Jackson

  Medtronic is suggesting health care professionals use mostly untested and unapproved software in backup controllers to help prevent HVAD restart failures.

• Another Medtronic HVAD System Recall Issued Over Battery Defects

  August 26, 2022

  Russell Maas

  More than 23,000 Medtronic HVAD heart implants are being recalled due to reports of battery failures which have led to at least one patient death.

• Medtronic Pacemaker Settlement Resolve Lawsuit Over Faulty Heart Implant

  August 11, 2022

  Irvin Jackson

  Medtronic has reached an undisclosed settlement with a man who says he was implanted with a defective pacemaker and had to undergo revision surgery.

• Medtronic HVAD Lawsuit Alleges Heart Pump Malfunctioned and Failed to Restart, Resulting in Fatal Injury

  June 20, 2022

  Irvin Jackson

  Hospital staff could do nothing but send a man home to die after his recalled Medtronic HVAD system failed to restart during a battery change, according to a recently filed lawsuit.

• Medtronic HVAD Pump Implant Kit Recall Issued Over Weld Defect

  June 9, 2022

  Russell Maas

  A bad pump weld in Medtronic HVAD systems, which were officially pulled from the market a year ago, has resulted in another Class I recall linked to at least one patient death.

• Medtronic Warns of HVAD Battery Problems Result in Another Recall

  May 6, 2022

  Irvin Jackson

  Medtronic is recalling hundreds of HVAD system batteries which may fail due to a welding defect which has already claimed one patient's life.

• Medtronic HVAD Systems Carry Pump Malfunction Risk, FDA Warns

  April 29, 2022

  Irvin Jackson

  The FDA warns that Medtronic HVAD devices, pulled from the market last year after thousands of patient deaths, may have pump weld defects which have cost the lives of at least two patients.

• HVAD Injury, Death Reports Long Before Recall Draw Questions from Congressional Oversight Subcommittee

  March 28, 2022

  Irvin Jackson

  A key U.S. lawmaker is asking the FDA to explain why it was slow to act on Medtronic HVAD system problems, despite receiving reports of patient injuries and deaths for years.