FDA announces Class I recalls for heart pump accessories due to safety risk

Abbott is recalling a piece of the mobile power units that go with some of its HeartMate 3 left ventricular assist devices (LVADs). The recall is due to some AC power cords failing to lock into place when inserted into the mobile power unit. This issue can cause the cords to work improperly, creating a risk for “hemodynamic compromise, thromboembolism or death” if not properly addressed.

Abbott is recommending that all impacted power cords be removed and replaced. However, the company is not recommending any replacements for the entire mobile power unit; only the power cords need to be replaced. 

“Abbott representatives will visit impacted clinics and evaluate the mobile power unit power-cord inventory,” according to an urgent notice sent to healthcare professionals back in June. “Any power cords that are identified with this issue will be replaced through Abbott Technical Services.”

The U.S. Food and Drug Administration (FDA) has categorized this as a Class I recall, which means the agency believes there is a risk of the issue leading to serious adverse health consequences, including death. At this time, however, no patient injuries have been reported. 

There are actually two separate Class I recalls. One Class I recall covers the mobile power units themselves and a second Class I recall covers standalone AC power cords.

A total of approximately 650 devices appear to be impacted by this issue. They were distributed in the United States, Canada and Japan in the months of May and June 2025.