19 results

• Abiomed Impella Lawsuit Alleges Heart Pump Caused Wrongful Death of Illinois Woman

  January 15, 2025

  Russell Maas

  A Missouri family has filed an Impella wrongful death lawsuit, alleging that the defective heart pump caused severe complications during cardiac surgery, leading to a preventable death.

• 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.

• Impella Left Sided Blood Pump Recall Issued Over Risk of Perforations Due to Faulty Instructions

  March 25, 2024

  Hannah Brown

  The Impella Left Sided Blood Pump recall warns that the device has been linked to heart perforations, resulting in severe injuries and deaths.

• 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.

• Abiomed Impella RP System Linked To Increased Risk Of Patient Deaths, FDA Warns

  February 6, 2019

  Irvin Jackson

  The FDA warns that the Abiomed Impella RP System has a higher rate of mortality among patients than its initial clinical trials predicted, potentially because the manufacturer did not take into account many real-world factors affecting patients.

• Abiomed AB5000 Circulatory Support System Recall: Risk of Injury or Death

  March 12, 2010

  Staff Writers

  A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined...