Class 2 Device Recall Impella 5.5 with SmartAssist S2

• Date Initiated by Firm: December 04, 2025
• Date Posted: January 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1030-2026
• Recall Event ID: 98086
• PMA Number: P140003
• Product Classification: Temporary non-roller type left heart support blood pump - Product Code OZD
• Product: Impella 5.5 with SmartAssist S2, Impella 5.5 with SmartAssist S2 Set, AU.
• Code Information: Catalog Number: 1000482; Australian Configuration Code: 1000770; GTIN: 00813502012828; Serial No. 621454 & 621455; Exp. Date 6/30/27.
• FEI Number: 1220648
• Recalling Firm/ Manufacturer: Abiomed, Inc.; 22 Cherry Hill Dr; Danvers MA 01923-2575
• For Additional Information Contact: Field Actions Team; 978-646-1400
• Manufacturer Reason for Recall: Device packaged in incorrect outer box carton.
• FDA Determined Cause: Under Investigation by firm
• Action: 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.
• Quantity in Commerce: 2 units
• Distribution: International distribution to the country of Australia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = OZD