FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
What this means
Abiomed has recalled certain low-profile introducer kits used with its Impella CP heart support device due to a potential risk of blood clot (thrombus) formation during prolonged use. The recall affects 17 units distributed in select US states and Japan.
- If you use or manage an Impella CP device with this introducer kit, contact your healthcare provider immediately to discuss your device and any needed follow-up.
- Do not discontinue use without medical guidance, as the device may be critical to your care.
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
17 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2600-2026More 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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