Abiomed recalls Impella 5.5 with SmartAssist devices

The FDA issued a field safety notice deeming a recall of Abiomed Impella 5.5 heart pumps as Class I, the most serious kind.

Abiomed — bought by Johnson & Johnson for $16.6 billion last year — recalled 466 affected devices. It distributed these Impella 5.5 with SmartAssist devices between Sept. 28, 2021, and March 6, 2023. The company initiated its recall on April 17. 2023.

This recall affects a subset of Impella 5.5 with Smart Assist systems. The latest versions with a preinstalled sidearm retainer and new yellow luer remain unaffected by this recall.

Impella 5.5 with SmartAssist supports the pumping chambers of the heart for up to 14 days when cardiogenic shock occurs less than 48 hours after a severe heart attack, open-heart surgery or when the heart functions poorly due to cardiomyopathy. Abiomed received customer complaints around the device relating to purge fluid leaking from the purge sidearm of the pump.

Purge leak occurrence leads to low purge pressures in the device, prompting alarms and requiring evaluation. If left unresolved, this issue could lead to pump stoppage and loss of therapy. Patients in critical condition could experience further deterioration and worsened conditions if the pump fails. It could lead to serious injury or death.

To date, Abiomed received 179 complaints related to the recall. It reports three injuries and no deaths as a result, according to the FDA notice.

Abiomed’s urgent medical device recall letter recommended users examine their inventory immediately. Customers should not use affected products unless they have no other available product. MassDevice