Abiomed recalls

Abiomed has 70 recalls on record with the FDA and USDA, the earliest in 2019 and the latest reported on 22 Jul 2026. 65 are still ongoing. 27 were reported in the last 12 months.

Total recalls70since 2019

Last 12 months27reported

Class I3956% of total

Ongoing65latest 22 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 2Jan '25 0 0 0Apr 0 0 0Jul 0 0 2Oct 0 0 1Jan '26 0 3 1Apr 0 3 17Jul 0 0

Severity split

Class I 39 56%Class II 31 44%Class III 0 0%

Why abiomed is recalled

Product types

Heart & Vascular Devices6897%
Other Medical Devices23%

By year

20262536%
202546%
20242840%
20231116%
202211%
201911%

Ongoing abiomed recalls

65 active

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Sterility	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 Smart Assist Set, JP, Pump Set Codes 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	Sterility	Nationwide

All abiomed recalls, newest first

70 total

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS I	Introducer Kit, Pump Set recalled by Abiomed	Abiomed	Sterility	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 Smart Assist Set, JP, Pump Set Codes 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	Sterility	Nationwide
22 Jul 2026Device	CLASS I	Impella 5 SmartAssist S2 Set, JP, Pump Set Codes 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

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.