18 results

• Impella Purge Cassettes Removed From Use Over Circulatory Support Failures: FDA

  February 26, 2026

  Michael Adams

  Federal regulators are urging hospitals and health care providers to immediately remove certain Impella heart pump purge cassettes from use due to risks of leaks or failures that may result in severe injury or death.

• 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.

• Top Medical Device Recalls and Warnings of 2025 Resulting in Lawsuits and Investigations

  December 29, 2025

  Irvin Jackson

  Several major recalls that occurred over the last two years are expected to have a significant impact on medical device and drug litigation throughout 2026.

• Abiomed, J&J Challenge Class Action Lawsuit Over Impella Heart Pump

  November 14, 2025

  Irvin Jackson

  Manufacturers seek to dismiss class action claims filed as part of wrongful death lawsuit linking the Impella heart pump to a man's death.

• Impella Heart Pump Lawsuit Updated With New Allegations Over Perforated Left Ventricle

  October 16, 2025

  Irvin Jackson

  A federal judge has tossed out a motion to partially dismiss an Impella heart pump wrongful death lawsuit after the plaintiff filed an amended complaint.

• Impella Heart Pump Cybersecurity Risks Result in FDA Recall Warning

  October 13, 2025

  Michael Adams

  Federal regulators have issued an early warning over a cybersecurity flaw in certain Automated Impella Controllers that, if exploited, could pose life-threatening risks to patients.

• Automated Impella Controller Warning Issued Due to Potential Cracks During Device Insertion, Removal

  September 24, 2025

  Michael Adams

  Amid ongoing Impella Heart Pump lawsuits, Abiomed has warned hospitals to pull certain controllers from use after safety issues were linked to risks of serious injury or death.

• Impella Heart Pump Controller Failure Linked to Patient Death, Resulting in FDA Warning

  August 28, 2025

  Irvin Jackson

  The FDA has issued an early warning for Impella heart pump automated controllers due to out-of-specification capacitors that may cause them to fail.

• Abiomed Challenges Impella Blood Pump Class Action Claims

  August 5, 2025

  Irvin Jackson

  The manufacturer is seeking the dismissal of an Impellla blood pump class action lawsuit alleging that a woman's husband died because the frequently recalled devices were defectively designed.

• Judge Rejects Lawsuit Over Impella Cardiac Device

  July 31, 2025

  Irvin Jackson

  An Impella wrongful death lawsuit has been dismissed after a judge determined the case was not pled in a way that the plaintiff could win.