FDA
Food and Drug Administration · Recall Z-2602-2026 · May 22, 2026Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
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 13 and 25 cm Japan. Product Code: 1000542.
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model Impella Set Product Code: 1000542Model GTIN: 813502013467Model Batch Number: 2041530.UPC 813502013467Would you have heard about this one?
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