FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
What this means
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.
The agency's original wording
Hazard
Potential for thrombus formation during prolonged use of the introducer.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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