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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
Related Medical Device Recalls
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Z-2599-2026 - Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434. 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Z-2600-2026 - Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435. 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Z-2602-2026 - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product Code: 1000542. 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
Z-2601-2026 - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834. 1 06/25/2026 FEI # 1220648
Abiomed, Inc.
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