Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAs... (Abiomed, Inc.) – device packaged in incorrect outer bo... (2025)
Incorrect packaging can potentially cause minor medical device identification issues.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
Brand
Abiomed, Inc.
Lot Codes / Batch Numbers
Catalog Number: 1000482, Australian Configuration Code: 1000770, GTIN: 00813502012828, Serial No. 621454 & 621455, Exp. Date 6/30/27.
Products Sold
Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.
Abiomed, Inc. is recalling Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU. due to Device packaged in incorrect outer box carton.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device packaged in incorrect outer box carton.
Recommended Action
Per FDA guidance
The consignee was sent a RECALL notice dated 12/4/25. The consignee is instructed to identify the two affected pumps in their inventory, quarantine them, and return the units to Abiomed, Danvers. The consignee is to complete and return the provided business reply form to their local Abiomed representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026