FDA-Device2026-07-01Class IPROCESSING DEFECT
Abiomed Impella CP Set with SmartAssist recalled for blood clot risk during prolonged use
OTHERNationwide distribution
Abiomed Impella CP Set recalled for blood clot risk
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.
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
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, Inc. recalls
- FDA-Device2026-07-01Abiomed Impella CP Low Profile Introducer Kit recalled for blood clot risk
- 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
Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief