24 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.

• 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.

• Medtronic HVAD Stroke Risk May Be Higher Than HeartMate3: Study

  August 19, 2021

  Irvin Jackson

  A new study reveals the recently recalled Medtronic Heartware HVAD system has more than double the risk of causing neurological adverse events in patients than the Abbott Heartmate3, which is still on the market, but plagued with problems of its own in recent years.

• Medtronic HeartWare Recall Given Most Serious Designation By FDA

  August 16, 2021

  Russell Maas

  The FDA says problems with Medtronic Heartware HVAD implants, which resulted in its removal from the market, put patients at risk of severe injury or death.

• HeartWare Heart Pump Problems Were Known, But Dangerous Implants Continued: Report

  August 13, 2021

  Irvin Jackson

  A new report indicates the FDA and Medtronic knew of HeartWare implant problems and deaths for years, but took little action to make the devices safer and kept allowing them to be implanted in the bodies of unsuspecting patients.