FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Set with SmartAssist recalled for blood clot risk during prolonged use
Abiomed Impella CP Set recalled for blood clot risk
Abiomed has recalled certain Impella CP Sets with SmartAssist (10th Generation) that contain affected 14Fr Low Profile Introducer Kits due to a potential for blood clot (thrombus) formation during prolonged use of the introducer. The affected units were distributed in the US and Japan.
- Contact Abiomed if you have one of the affected units (Product Code 1000542, Batch Number 2041530).
- Follow guidance from your healthcare provider regarding your device.
Hazard
Potential for thrombus formation during prolonged use of the introducer.
Who it affects
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
7 units
Manufactured in
22 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2026More 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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