BfArM - Federal Institute for Drugs and Medical Devices

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Product group Medical electronics / Electromedical devices
Reference 02414/10

ABIOMED Europe GmbH has issued a Field Safety Notice concerning the recall of Impella® 5.0. The root cause is a failure in one production batch with the risk of device rupture and subsequent loss of pump support or even loss of components.

Recall for Impella® 5.0, ABIOMED , Download_VeroeffentlichtAm_EN PDF, 102KB, File is accessible

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