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U.S. Department of Health and Human Services

Medical Device Recalls
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Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 2 07/10/2026 FEI # 3001675293
Intuitive Surgical, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. hear... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, S... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introd... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introd... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Pro... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer P... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.

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