FDA
Food and Drug Administration · Recall Z-2601-2026 · May 22, 2026Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Abiomed, Inc.
The hazard
Potential for thrombus formation during prolonged use of the introducer. FDA Class I recall.
The remedy
Follow FDA guidance
About this recall
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1. Impella Set Product Code: 1000413Model GTIN: 00813502013566Model Serial numbers: 649727Model 649728Model 649729Model 649730Model 649731Model 654349Model 654348Model 654342Model 654341Model 654340Model 654339Model 654338Model 654336Model 654335Model 654334Model 654333Model 653010Model 653009Model 653008Model 653007Model 653006Model 653005Model 653004UPC 00813502013566UPC 00813502013948Would you have heard about this one?
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