J&J’s Abiomed Recalls Impella Controllers After Device-Linked Death

Johnson & Johnson’s Abiomed is recalling certain automated controllers used with its Impella heart pumps after a patient's death was linked to a manufacturing defect. The FDA issued an early alert stating that 69 controllers contain pump driver circuit assemblies with 25v-rated capacitors instead of the required 35v, a flaw that could impair pump performance, trigger failure alarms, or cause the pump to stop, risking loss of circulatory support. As of August 12, one death and no serious injuries have been reported.

Abiomed has advised healthcare providers to quarantine the affected devices and contact the company for remediation. Loaner controllers will be supplied. J&J noted the failure rate was 0.006% in reviews of complaints from 2011 to mid-2025. The recall adds to Abiomed’s recent regulatory challenges, including a 2023 FDA warning letter and other Impella-related recalls. J&J purchased Abiomed in 2022 for $16.6 billion.

28-08-2025