FDA issues early alert on Abiomed Impella controller safety issue

The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers.

Abiomed has sent a letter to affected customers recommending removal of specific Impella controllers identified by serial numbers and product numbers from use or sale until they receive hardware, firmware, or software updates. The devices listed include Impella Controller Packaged (US0042-0000), Impella Optical Controller (US0042-0010), and Optical AIC Impella Controller (US0042-0040).

While awaiting service, hospitals may continue to use existing inventory to maintain patient care, but they should coordinate removal, updates, and return of the impacted units with Abiomed as soon as possible. The FDA will update the page as new information becomes available.