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MEDICAL DEVICE RECALLCRITICAL
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP
Abiomed recalls Impella CP introducer kit over thrombus risk.
What to do
Stop using the affected introducer kit immediately. Contact Abiomed for instructions on returning the product and obtaining a replacement.
Why it was recalled
Abiomed is recalling the 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP (Product Code 1000434) due to the potential for thrombus formation during prolonged use of the introducer.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
| Product | UPC | Recall # |
|---|---|---|
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. | 00813502013566, 2026724558, 2027818724, 00813502013948, 2026787668, 2027818660 | Z-2601-2026 |
| Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. | 00813502013009 | Z-2600-2026 |
| Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. | 00813502012996 | Z-2599-2026 |
| Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. | 813502013467 | Z-2602-2026 |
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from Abiomed, Inc.
Editorial summary by Recall Canary · last updated 2026-07-28 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification