Abbott has issued a recall for select HeartMate mobile power units used with its HeartMate3 and HeartMate III left-ventricular assist systems due to risk of sudden power loss that could lead to serious injury or death.
The recall affects power units distributed between April 2024 and February 2025, which may experience unexpected shutdowns, failure to power on, or restarts linked to a faulty electrical component, according to an April 24 FDA news release.
Patients were advised to immediately switch to fully charged 14-volt rechargeable batteries if they encounter any visual or audio alarms. Failure to act within 15 minutes of power unit failure could result in the pump shutting down, precipitating life-threatening complications such as impaired blood flow or clot formation.
No deaths or injuries have been reported.
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