FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Set with SmartAssist recalled for blood clot risk during prolonged use
What this means
Certain lots of the Abiomed Impella CP Set with SmartAssist (10th Generation) and its 14Fr Low Profile Introducer Kit may form blood clots during extended use. The affected units have specific serial numbers and batch numbers listed by the FDA. No injuries have been reported.
- Check your device serial number and introducer batch number against the FDA's affected list.
- Contact your healthcare provider or Abiomed if you have an affected unit.
- Do not remove the device without medical guidance.
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
168 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. Product Codes: 1000413, 1000834.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2601-2026More 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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