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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 4 of 4 Results
510(K) Number: K241708
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Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. ... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. ... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Intro... 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
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