Dive Brief:
- Johnson & Johnson’s Abiomed has recalled certain Impella heart pumps over a problem linked to one death, the Food and Drug Administration said Wednesday. The recall, which the FDA disclosed in an early alert notice, affects seven Impella CP Sets with SmartAssist that do not meet design specifications, J&J said in an email to MedTech Dive. An internal review led to the recall.
- Affected devices may experience low purge pressure events from the onset of the case, leading to pump exchanges that can cause serious injuries and death.
- A review of global complaints from Jan. 1, 2024 to April 12, 2026 identified the issue in 0.01% of cases, a J&J spokesperson said in the email. Twelve complaints were reported, out of 107,277 cases.
Dive Insight:
The recalled devices provide temporary ventricular support in elective or urgent high-risk percutaneous coronary interventions. Physicians use the pumps after determining high-risk PCI is the appropriate treatment for hemodynamically stable patients with severe coronary artery disease.
J&J bought Abiomed for $16.6 billion in 2022. The J&J spokesperson said that as part of the integration, J&J completed a number of comprehensive, retrospective audits of its quality system and processes that resulted in field actions in some cases. “These field actions do not compromise the safety of the products in use today. Rather, they demonstrate that our enhanced processes are rigorous and working as intended,” the spokesperson wrote.
Abiomed wrote to customers on May 18 to recommend they quarantine and return devices affected by its latest recall. The letter was triggered by the discovery of out-of-specification devices that can cause persistent low purge pressure alarms. In some cases, mechanical circulatory support can be interrupted or lost because of the problem.
“Loss of support may lead to an acute change in care when the pump is exchanged, hypotension, end organ hypoperfusion and risk of death if not promptly corrected,” the FDA said.
As of May 7, Abiomed had reported three pump exchanges, which could cause serious injuries, and one death associated with the issue. The death is the latest fatality associated with Abiomed devices, which are used in high-risk patients. In 2024, the FDA shared an issue associated with 49 deaths. Last week, the agency published an early alert notice about a problem associated with one death.
The string of recalls and corrections covers Impella pumps and the devices used to control them. While the portfolio has faced problems, Abiomed has remained a growth driver for J&J. The business grew 16.3% in the first quarter, helping to cement cardiovascular disease as a key area for J&J’s medtech business.
