15 results

• Impella Catheter Introducer Kit Warning Issued Over Blood Clot Formations: FDA

  June 4, 2026

  Darian Hauf

  Federal regulators have expanded a series of Impella heart pump recalls and safety alerts, warning that certain catheter introducer kits used with the devices may increase the risk of thrombus formation.

• 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.

• 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 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.

• Impella Pump Lawyers Involved in Class Action Lawsuit To Meet With Judge July 29

  June 25, 2025

  Irvin Jackson

  Lawyers will meet with a federal judge for the first time next month to brief the court on a recently-filed Impella class action lawsuit and how the litigation should proceed.

• Impella Pump Class Action Lawsuit Alleges Defects Caused Perforated Left Ventricle, Wrongful Death

  June 2, 2025

  Irvin Jackson

  A widow has filed an Impella heart pump class action lawsuit following the discovery that her husband's death was likely linked to the implant piercing his heart.