FDA
Food and Drug Administration · Recall Z-2600-2026 · May 22, 2026Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
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 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
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: 1000435Model GTIN: 00813502013009Model Serial Numbers: N/A. Introducer Product Code: 1000435Model Batch Numbers: 2038707Model 2045782.UPC 00813502013009Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.