J&J's Abiomed unit recalls Impella 5.5 heart pumps over safety concerns
Mario Tama
Johnson & Johnson's (NYSE:JNJ) Abiomed unit has issued a recall for some of its Impella 5.5 with Smart Assist heart pumps over concerns that leaks could cause the pump to stop, which could result in serious injury or even death.
Abiomed issued a Class I recall for the device, the most serious type under FDA guidelines. The recall was issued after 179 customers complained of purge fluid leaking from the device's purge sidearm, which could cause the pump to stop if not resolved, according to the FDA's product recall webpage.
The FDA added that Abiomed had reported three injuries but no deaths related to the recalled device. Abiomed first sent a letter to customers advising them of an urgent recall on April 17.
The Impella 5.5 is intended to be used for up to 14 days to support heart function in patients experiencing ongoing cardiogenic shock that occurs within 48 hours of a severe heart attack, open-heart surgery or due to cardiomyopathy, according to the FDA's website.
Abiomed was acquired by Johnson & Johnson in December 2022.
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