FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
OTHERNationwide distribution
Abiomed Impella CP Introducer Kit recalled for blood clot risk
Abiomed's 14 Fr x 13 cm Low Profile Introducer Kit for the Impella CP heart pump may increase the risk of blood clot (thrombus) formation during extended use. Three units have been distributed to hospitals in the US and Japan.
- If you are a hospital or medical facility with this introducer kit, contact Abiomed immediately for guidance.
- Do not use this product for new patients until you receive instructions from Abiomed.
- Review patient records for anyone who received this device and discuss any symptoms of blood clots with their doctor.
Hazard
Potential for thrombus formation during prolonged use of the introducer.
Sold states
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Affected count
3 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2599-2026More Abiomed, Inc. recalls
- FDA-Device2026-07-01Abiomed Impella CP Set with SmartAssist recalled for blood clot risk during prolonged use
- FDA-Device2026-07-01Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
- FDA-Device2026-07-01Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
- FDA-Device2026-06-24Abiomed Impella CP Set with SmartAssist recalled for mechanical support interruption risk
- FDA-Device2026-06-24Abiomed Impella Controller recalled for software error risk
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