Abiomed recalls

Abiomed has 74 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 30 Sep 2026. 69 are still ongoing. 30 were reported in the last 12 months.

Total recalls74since 2019

Last 12 months30reported

Class I4257% of total

Ongoing69latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 0 0 0May 0 0 0Aug 0 2 0Nov 0 1 0Feb 3 1 0May 3 17 0Aug 4 0

Severity split

Class I 42 57%Class II 32 43%Class III 0 0%

Why abiomed is recalled

Product types

Heart & Vascular Devices7297%
Other Medical Devices23%

By year

20262939%
202545%
20242838%
20231115%
202211%
201911%

Ongoing abiomed recalls

69 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller with the below product recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide

All abiomed recalls, newest first

74 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Potency & Assay	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller, Automated Impella Controller recalled	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Impella Optical Controller with the below product recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
23 Sep 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Intro Kitand, PKGD, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella 5.5 Smart Assist Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Set, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella RP Flex with SmartAssist Set, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella 5.5 SmartAssist S2 Set, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Set, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Insertion Kit, Pkgd, JP, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Introducer Kit, 13 and, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
22 Jul 2026Device	CLASS I	Impella CP Set, Pump Set recalled by Abiomed	Abiomed	Packaging Defects	Nationwide
1 Jul 2026Device	CLASS I	Impella CP Set with SmartAssist (10th Generation) recalled by Abiomed	Abiomed	Other	Nationwide
1 Jul 2026Device	CLASS I	Low Profile Introducer Kit for Impella CP. Impella Set recalled	Abiomed	Other	Nationwide
1 Jul 2026Device	CLASS I	Low Profile Introducer Kit for Impella CP. Impella Set recalled	Abiomed	Other	Nationwide
1 Jul 2026Device	CLASS I	Impella CP Set with SmartAssist (10th Generation) recalled by Abiomed	Abiomed	Other	Nationwide
24 Jun 2026Device	CLASS I	Impella CP Set with SmartAssist recalled by Abiomed	Abiomed	Device Malfunction	7 states
3 Jun 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
3 Jun 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Labeling Errors	Nationwide
8 Apr 2026Device	CLASS I	Automated Impella Controller (AIC) recalled by Abiomed	Abiomed	Device Malfunction	MA
11 Mar 2026Device	CLASS I	Impella RP recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS I	Impella RP with SmartAssist recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
11 Mar 2026Device	CLASS I	Impella RP Flex with SmartAssist recalled by Abiomed	Abiomed	Device Malfunction	Nationwide
14 Jan 2026Device	CLASS II	Impella 5.5 with SmartAssist¿ S2, Impella recalled by Abiomed	Abiomed	Packaging Defects	MA
15 Oct 2025Device	CLASS I	Automated Impella Controller (AIC), used recalled by Abiomed	Abiomed	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.