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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 20 Results
510(K) Number: K192769
 
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Product Description
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ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr I... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052... 1 07/10/2026 FEI # 1220648
Abiomed, 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 Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product C... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. hear... 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.
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 RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm ... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing Introducer ... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
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