9 results

• 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.

• Abiomed Impella RP Heart Pump Side Effects May Include High Rate Of Patient Deaths, FDA Warns

  May 22, 2019

  Martha Garcia

  The FDA warns that a heart pump used for emergency procedures has a high rate of death among some types of 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...

• Thoratec HeartMate II Blood Pump Warning: Lead May Fail

  October 27, 2008

  AboutLawsuits

  Thoratec Corporation has warned that their HeartMate II blood pump may fail due to a defective lead that connects the...