FDA-Device2026-01-14Class IIPACKAGING DEFECT
Abiomed Impella 5.5 with SmartAssist S2 recalled for incorrect packaging
What this means
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
The agency's original wording
Hazard
Device packaged in incorrect outer box carton.
Intended for
Adults
Illnesses reported
None reported
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 recalls
- FDA-Device2026-07-22Abiomed Introducer Kit 23 Fr recalled for potential sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella CP Smart Assist Set recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Intro Kit heart pump introducer recalled for potential fluid leakage risk
- FDA-Device2026-07-22Abiomed Impella CP heart pump recalled for introducer sheath leakage risk
- FDA-Device2026-07-22Abiomed Impella 5.5 Smart Assist Set recalled for introducer sheath leakage risk
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