Abiomed recalls Impella 5.5 with SmartAssist S2 devices due to incorrect outer packaging. Affected units have specific serial numbers and Australian configuration codes. No action is required as the packaging error does not affect safety.
“Abiomed Impella 5.5 SmartAssist S2: Incorrect Packaging Recalled.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50532-abiomed-impella-5-5-smartassist-s2-incorrect-packaging-recalled. Based on FDA recall #Z-1030-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1030-2026%22&limit=1).
Abiomed, Inc. voluntarily recalled six Impella 5.5 with SmartAssist S2 Set units distributed to Australia and Taiwan due to packaging in an incorrect outer box carton, the FDA said on Dec. 4, 2025.
How to tell if you have it
Brand: Abiomed
Product: Impella 5.5 with SmartAssist S2 Set, AU
Catalog Number: 1000482
Australian Configuration Code: 1000770
UPC/GTIN: 00813502012828
Serial Numbers: 621454, 621455, 621448, 621449, 621450, 621451
Expiration Date: 6/30/27
The hazard
The FDA stated the hazard is that the device was packaged in an incorrect outer box carton.
Context
GovInfoNow's records show Abiomed, Inc. has had 28 other recalls on record since Sept. 4, 2019. Other recent recalls of similar products include Abiomed Impella Optical Controller Recall (Aug. 12, 2026), Abiomed Impella CP Set Recall (June 11, 2026), and Abiomed 14 Fr Introducer Kit Recall (May 22, 2026).
How to tell if you have this one
Check for serial numbers 621448-621455 on the device packaging. The Australian Configuration Code 1000770 and GTIN 00813502012828 also identify affected units.
Brand
Abiomed
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Packaging
Verify the serial numbers on the device packaging to confirm if it is affected.
How this recall unfolded
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1030-2026 (December 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1030-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.