Abiomed, Inc. recalls Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssi
See all recalls from Abiomed, Inc. →Recalled Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Hazard / Issue
Device packaged in incorrect outer box carton.
Issued by
FDA
Distribution: International distribution to the country of Australia.
Lot/Code Info: Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
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