⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Is Abiomed recalled?

Abiomed recalls - full list & free alerts

Official U.S. agency records list 32 recalls involving Abiomed in the last 12 months, most recently on 2026-09-30. Check each official notice for the exact products, lot codes and dates affected.

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Recalls (32)

Abiomed, Inc.: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,
Medical DevicesFDA (device) · 2026-09-30 · Class II
Abiomed, Inc.: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA;
Medical DevicesFDA (device) · 2026-09-23 · Class I
Abiomed, Inc.: Impella Optical Controller with the below product descriptions and corresponding Product Codes. 1. Impella Optical Controller, Packaged, AU;
Medical DevicesFDA (device) · 2026-09-23 · Class I
Abiomed, Inc.: Impella Optical Controller, Automated Impella Controller, Impella Connect Package with the below product descriptions and corresponding Prod
Medical DevicesFDA (device) · 2026-09-23 · Class I
Abiomed, Inc.: ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm, Sterile, 23 Fr, 11 cm, Product C
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: 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 DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr Introducer, 13cm&25cm, Sterile, Introduce
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile, Introducer Product Code 2000342.
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer, 13cm, Long Taper, Introducer Produ
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer, 25cm, Long Taper, Introducer Produ
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing Introducer Product Code 0052-3006-JP. heart pump and
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing Introducer Product Code 0052-3006-JP. heart pump an
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code 0052-3046. heart pump and accessories
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and access
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. heart pump and accessories
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer Product Code 0052-3006-JP. heart pump and accessories
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: 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 a
Medical DevicesFDA (device) · 2026-07-22 · Class I
Abiomed, Inc.: Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000434. Introducer Product Code: 1000434.
Medical DevicesFDA (device) · 2026-07-01 · Class I
Abiomed, Inc.: Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Code: 1000435. Introducer Product Code: 1000435.
Medical DevicesFDA (device) · 2026-07-01 · Class I
Abiomed, Inc.: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000
Medical DevicesFDA (device) · 2026-07-01 · Class I
Abiomed, Inc.: Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits 13 and 25 cm Japan. Product C
Medical DevicesFDA (device) · 2026-07-01 · Class I
Abiomed, Inc.: Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes:
Medical DevicesFDA (device) · 2026-06-24 · Class I
Abiomed, Inc.: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Medical DevicesFDA (device) · 2026-06-24 · Class I
Abiomed, Inc.: Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Medical DevicesFDA (device) · 2026-06-03 · Class I
Abiomed, Inc.: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged,
Medical DevicesFDA (device) · 2026-06-03 · Class I
Abiomed, Inc.: Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and correspondi
Medical DevicesFDA (device) · 2026-04-08 · Class I
Abiomed, Inc.: Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Prod
Medical DevicesFDA (device) · 2026-04-08 · Class I
Abiomed, Inc.: Impella RP with SmartAssist. Product Code: 0046-0035.
Medical DevicesFDA (device) · 2026-03-11 · Class I
Abiomed, Inc.: Impella RP Flex with SmartAssist. Product Code: 1000323.
Medical DevicesFDA (device) · 2026-03-11 · Class I
Abiomed, Inc.: Impella RP. Product Code: 0046-0011.
Medical DevicesFDA (device) · 2026-03-11 · Class I
Abiomed, Inc.: Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Medical DevicesFDA (device) · 2026-01-14 · Class II
Abiomed, Inc.: Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Cod
Medical DevicesFDA (device) · 2025-10-29 · Class I
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