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Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product C
Recalled July 1, 2026 · FDA recall Z-2600-2026 · Abiomed
Hazard
Potential for thrombus formation during prolonged use of the introducer. · FDA Class I
Units
17 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 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →