Product Safety Recalls

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Abiomed, Inc. Recall 92321

Description: Impella LD intravascular micro axial blood pump, Product Number 005082

Abiomed, Inc. Recall 92321 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2113-2023
Event ID92321
Event DescriptionImpella LD intravascular micro axial blood pump, Product Number 005082
Product TypeDevices
DistributionWorldwide distribution - US Nationwide.
Quantity9252 units
Recall ReasonThere is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
Device Classification20230726
Device Code InfoUDI-DI: 00813502011227;
Center Classification Date20230714
Recall Initiation Date20230614
Recalling FirmAbiomed, Inc.
Initial Notification Letter
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