13 results

• FDA Warning Issued Over Impella CP Sets With SmartAssist, After Patient Death

  May 28, 2026

  Michael Adams

  Federal regulators have announced a new safety alert for certain Abiomed Impella CP Sets with SmartAssist, after a defect with the heart pumps was linked to at least one death.

• Impella Heart Pump Warning Issued Over Controller Malfunction Risks: FDA

  May 22, 2026

  Michael Adams

  Federal regulators are warning that a software malfunction in Abiomed Impella heart pump controllers may cut off cardiac support for critically ill patients, with the issue already linked to two serious injuries and one death.

• Abbott HeartMate 3 Lawsuit Alleges Pump Failure Led to Man’s Death

  March 3, 2026

  Irvin Jackson

  A wrongful death lawsuit filed on behalf of a Texas man alleges he was implanted with a defective HeartMate 3 heart pump after the manufacturers already knew there was a problem.

• Impella Heart Pump Sensor Warning Issued by Abiomed After Nearly Two Dozen Injuries: FDA

  February 4, 2026

  Michael Adams

  Federal regulators have issued a warning that certain Abiomed Impella heart pumps may display inaccurate data due to a sensor malfunction, following earlier recalls and lawsuits that allege other potential risks.

• Impella Pump Heart Perforation Problems Were Not Adequately Disclosed to FDA: Report

  April 9, 2024

  Russell Maas

  FDA letter accuses Abiomed of not reporting heart-tearing incidents linked to the recalled Impella devices as required by law.

• Abiomed Impella Recall Issued For Heart Pump Catheter’s Instructions Due to Blood Clot Risks

  August 21, 2023

  Katherine McDaniel

  The third Impella heart pump recall in as many months warns that they lack instructions for doctors on the risks of blood clots linked to the devices.

• Impella Left Sided Blood Pump Recall Issued Due to Risk Contact with TAVR Stents May Cause Motor Damage

  July 28, 2023

  Irvin Jackson

  The FDA warns about 8,000 Abiomed Impella blood pumps may suffer motor damage when placed too close to TAVR valves, leading to an increased risk of severe injury and death.

• Impella 5.5 Heart Pump Recall Follows Reports of Fluid Leaks and Patient Injuries

  June 6, 2023

  Stephanie Yanovich

  Nearly 500 Impella 5.5 heart pumps by Abiomed have been recalled following reports of fluid leaks, pump failures and patient injuries.

• New Clinical Data Shows Abiomed Impella RP Heart Pump is Safe, Despite Concerns Over Patient Deaths: FDA

  December 6, 2022

  Russell Maas

  The FDA has released clinical trial data on Abiomed Impella RP Heart Pump Systems, declaring the device safe, but updated its warning label to recommend it only be used on certain patients.

• 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.