FDA-Device2026-01-14Class IIPACKAGING DEFECT
Abiomed Impella 5.5 with SmartAssist S2 recalled for incorrect packaging
OTHERNationwide distribution
Check Abiomed Impella 5.5 packaging
Abiomed has recalled 2 units of the Impella 5.5 with SmartAssist S2 heart pump device because the devices were shipped in incorrect outer box cartons. This packaging error may affect proper device identification and handling. No injuries have been reported.
- If you have received an Impella 5.5 with SmartAssist S2 (serial numbers 621454 or 621455, expiration 6/30/27), contact Abiomed or your hospital supply department immediately
- Verify the device serial number and outer box labeling before use
Hazard
Device packaged in incorrect outer box carton.
Sold states
International distribution to the country of Australia.
Affected count
2 units
Manufactured in
22 Cherry Hill Dr, Danvers, MA, United States
Products
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1030-2026More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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