Class IIReported 2026-01-14
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Recalled by Abiomed, Inc.
Reason for Recall
Device packaged in incorrect outer box carton.
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Recall NumberZ-1030-2026ClassificationClass IIStatusOngoingCategorydeviceInitiated2025-12-04Reported2026-01-14DistributionInternational distribution to the country of Australia.Code InfoCatalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.