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Abiomed Recalls the Instructions for Use for the Impella Left Sided Blood Pumps due to Perforation Risks
Abiomed is recalling the Instructions for Use for its Impella Left Sided Blood Pumps because the pump catheter may perforate (cut) the wall of the left ventricle in the heart. During operations, the Impella device could cut through the wall of the left ventricle.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Questions?
If you have questions about this recall, contact Abiomed, Inc. at (978) 646-1400.
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