CLASS II ONGOING Device recall · Reported 14 Jan 2026 · FDA Enforcement Report
Impella 5.5 with SmartAssist¿ S2, Impella recalled by Abiomed
Abiomed is recalling Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU. The recall was initiated on 4 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1030-2026
- FDA event ID
- 98086
- Recalling firm
- Abiomed, Danvers, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2025
- FDA classified
- 8 Jan 2026
- Reported
- 14 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 4 Dec 2025 | Recall initiated by company | |
| 8 Jan 2026 | Classified by FDA | +35 days |
| 14 Jan 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Device packaged in incorrect outer box carton.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Where it was distributed
International distribution to the country of Australia and Taiwan.
Questions about this recall
Why was it recalled?
Device packaged in incorrect outer box carton.
Which lots are affected?
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27. *** UPDATE 05/02/2026*** Serial numbers added: 621448, 621449, 621450, and 621451;
Where was it sold?
International distribution to the country of Australia and Taiwan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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