← All recallsAll Abiomed, Inc. Recalls
Medical Device2026-07-22
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342.Medical Device2026-07-22
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessMedical Device2026-07-22
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 aMedical Device2026-07-22
ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and Medical Device2026-07-22
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessoriesMedical Device2026-07-22
ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product CMedical Device2026-07-22
ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump anMedical Device2026-07-22
ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer ProduMedical Device2026-07-22
ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessoriesMedical Device2026-07-22
ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessoriesMedical Device2026-07-22
ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, IntroduceMedical Device2026-07-22
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer ProduMedical Device2026-07-22
ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart Medical Device2026-07-01
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product CMedical Device2026-07-01
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.Medical Device2026-07-01
Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.Medical Device2026-07-01
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000Medical Device2026-06-24
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: Medical Device2026-06-24
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Medical Device2026-06-03
Automated Impella Controller (AIC); Product Code: 0042-0000-US;Medical Device2026-06-03
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, Medical Device2026-04-08
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and correspondiMedical Device2026-04-08
Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; ProdMedical Device2026-03-11
Impella RP. Product Code: 0046-0011.Medical Device2026-03-11
Impella RP with SmartAssist. Product Code: 0046-0035.Medical Device2026-03-11
Impella RP Flex with SmartAssist. Product Code: 1000323.