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Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product
Recalled July 1, 2026 · FDA recall Z-2601-2026 · Abiomed
Hazard
Potential for thrombus formation during prolonged use of the introducer. · FDA Class I
Units
168 units
Sold at
Worldwide - US Nationwide distribution in the states of FL, IL, MN, NJ, NY, VA and the country of Japan.
Description
Potential for thrombus formation during prolonged use of the introducer.
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →