35 results

• Impella Heart Pump Lawsuit

  June 5, 2026

  Russell Maas

• 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 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.

• 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.