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Abiomed Recalls Impella Heart Pumps Due to Safety Concerns

Nearly 200 complaints prompted a Class I recall of the 5.5 model heart pumps.

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Abiomed

According to a recent Fierce Biotech article, medical device manufacturer Abiomed has issued a recall for several hundred units of its Impella heart pumps due to nearly 200 complaints. The FDA has classified the recall as Class I, indicating a high risk of injury or death. The recall does not include all Impella 5.5 pumps, but the affected devices are part of the Impella 5.5 model, used to support cardiac function in patients with specific heart conditions. The recall was prompted by reports of purge fluid leakage, potentially leading to pump malfunction and worsening of patients' heart conditions. 

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