FDA-Device2026-07-01Class I
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542.
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
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, 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 Low Profile Introducer Kit recalled for blood clot risk
- 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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