FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
OTHERNationwide distribution
Abiomed Impella CP introducer recalled for blood clot risk
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.
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
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, 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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