Abiomed recalls
Abiomed appears in 79 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-22.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introduc…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Prod…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Set, Pump Set Code 0048-0044
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm, Product Code 0052-3046. heart…
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella CP Set, Pump Set Code 0048-0014
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP
FDA Device · Class I · 2026-07-22 · Abiomed - ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460
FDA Device · Class I · 2026-07-22 · Abiomed - Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435
FDA Device · Class I · 2026-07-01 · Abiomed - Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434
FDA Device · Class I · 2026-07-01 · Abiomed - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits
FDA Device · Class I · 2026-07-01 · Abiomed - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan
FDA Device · Class I · 2026-07-01 · Abiomed - Automated Impella Controller (AIC), for use with left heart support blood pump
FDA Device · Class I · 2026-06-24 · Abiomed - Impella CP Set with SmartAssist
FDA Device · Class I · 2026-06-24 · Abiomed - Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-06-03 · Abiomed - Automated Impella Controller (AIC)
FDA Device · Class I · 2026-06-03 · Abiomed - Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA
FDA Device · Class I · 2026-04-08 · Abiomed - Purge Cassette, sold within Impella Pump Sets and Individually Packaged
FDA Device · Class I · 2026-04-08 · Abiomed - Impella RP with SmartAssist
FDA Device · Class I · 2026-03-11 · Abiomed - Impella RP Flex with SmartAssist
FDA Device · Class I · 2026-03-11 · Abiomed - Impella RP. Product Code: 0046-0011
FDA Device · Class I · 2026-03-11 · Abiomed - Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU
FDA Device · Class II · 2026-01-14 · Abiomed - Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Cod…
FDA Device · Class I · 2025-10-29 · Abiomed - Automated Impella Controller (AIC), used for left heart support blood pump, labeled as the following with corresponding Product Codes: 1. I…
FDA Device · Class I · 2025-10-15 · Abiomed - Automated Impella Controller (AIC) with the below brands and product codes
FDA Device · Class I · 2025-10-01 · Abiomed - Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 1. Impella Controller, Packaged, AU
FDA Device · Class I · 2025-08-06 · Abiomed - Impella RP Flex with SmartAssist
FDA Device · Class I · 2025-01-22 · Abiomed - Impella RP with SmartAssist
FDA Device · Class I · 2025-01-22 · Abiomed - Pump 371 14F LT CMR Set
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 SmartAssist Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 SmartAssist S2 Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Pump Set, Japan
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set APAC
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist S2 Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - Pump 381 Pump Set (US)
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Pump 371 Set, Clinical Trial
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set, EU
FDA Device · Class II · 2024-09-11 · Abiomed - ImpellaCP SmartAssistSetAPAC, Delo1895
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist S2 Set, US
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set, JP
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist Set, CA
FDA Device · Class II · 2024-09-11 · Abiomed - Impella CP Smart Assist Set, Canada
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 Set AU
FDA Device · Class II · 2024-09-11 · Abiomed - Impella 5.5 with SmartAssist Set, US
FDA Device · Class II · 2024-09-11 · Abiomed