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BioWorld - Thursday, May 14, 2026
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Home » Abiomed recalls Impella devices citing risk of ventricle perforation
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Abiomed recalls Impella devices citing risk of ventricle perforation

March 22, 2024
By Mark McCarty
The U.S. FDA posted notice of a medical device correction of Abiomed Inc.'s Impella series of left-side blood pumps because of the risk of perforation of the left ventricle during device placement. The FDA noted that it has received 129 reports of serious injury and 49 reports of fatalities associated with these devices, but did not indicate whether device malfunction was the source of these adverse events. Abiomed advises customers that the device should be implanted “with special care” in patients during active cardiopulmonary resuscitation, and to review some updated warnings in the product’s instruction for use statement.
Medical technology Regulatory Cardiovascular Respiratory U.S.

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