At a Glance

  • Johnson & Johnson's Abiomed has recalled some Impella heart pumps linked to a death, the U.S. Food and Drug Administration said in an early alert Wednesday. The recall involves seven Impella CP SmartAssist devices that did not meet design specifications, and Johnson & Johnson said in an email to MedTech Dive that an internal review prompted the recall.
  • Affected devices may experience low perfusion pressure events at the start of the procedure, leading to pump replacement, which could result in serious injury or death.
  • A Johnson & Johnson spokesperson said in an email that a review of global complaints from Jan. 1, 2024, to April 12, 2026, found the issue occurred at a rate of 0.01%. Among 107,277 cases, 12 complaints were reported.

Deep Dive

The recalled devices are used to provide temporary ventricular support during elective or emergency high-risk percutaneous coronary intervention (PCI). Physicians use these pumps after determining that high-risk PCI is an appropriate treatment option for patients with severe coronary artery disease who are hemodynamically stable.

Johnson & Johnson acquired Abiomed in 2022 for $16.6 billion. A Johnson & Johnson spokesperson said that during integration, Johnson & Johnson conducted multiple comprehensive retrospective audits of its quality systems and processes and, in some cases, took field actions. The spokesperson wrote: "These field actions do not impact the safety of products currently in use. Rather, they demonstrate that our strengthened processes are rigorous and working as intended."

Abiomed sent a letter to customers on May 18 advising them to quarantine and return devices affected by the latest recall. The letter was triggered by the discovery that devices not meeting specifications could lead to persistent low perfusion pressure alarms. In some cases, mechanical circulatory support may be interrupted or lost due to this issue.

"If support is interrupted during pump replacement, it could lead to acute clinical deterioration, hypotension, end-organ hypoperfusion, and risk of death if not promptly corrected," the FDA said.

As of May 7, Abiomed has reported 3 pump replacement events (which could lead to serious injury) and 1 death related to the issue. This death is the latest associated with Abiomed devices used in high-risk patients. In 2024, the FDA disclosed a problem linked to 49 deaths. Last week, the agency also issued an early alert about a death-related issue.

This series of recalls and corrective actions covers Impella pumps and their control devices. Despite issues with the product portfolio, Abiomed remains a growth driver for Johnson & Johnson. The business grew 16.3% in the first quarter, further solidifying cardiovascular disease as a key area for Johnson & Johnson's MedTech business.