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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 13 Results
Related Medical Device Recalls
 
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Z-2681-2026 - ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product Code 2000342. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2682-2026 - ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2683-2026 - ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introducer Product Code 0052-3046. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2684-2026 - ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2685-2026 - ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Product Code 0052-3052. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2686-2026 - ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Product Code 0052-3053. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2693-2026 - ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2688-2026 - ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2689-2026 - ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
Z-2690-2026 - ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
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