Class 1 Device Recall Impella CP Set with SmartAssist

• Date Initiated by Firm: May 18, 2026
• Date Posted: June 18, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2457-2026
• Recall Event ID: 98946
• PMA Number: P140003
• Product Classification: Temporary non-roller type left heart support blood pump - Product Code OZD
• Product: Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
• Code Information: GTIN: 00813502012279. Product Codes (Serial Number): 1000080 (677223, 672986, 673252, 644591, 645428, 644314, 613525), 1000851 (636173), 0048-0014 (499250), 0048-0024-JP (661216).
• FEI Number: 1220648
• Recalling Firm/ Manufacturer: Abiomed, Inc.; 22 Cherry Hill Dr; Danvers MA 01923-2575
• For Additional Information Contact: Morgaine Johnson; 978-646-1400
• Manufacturer Reason for Recall: Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
• FDA Determined Cause: Under Investigation by firm
• Action: Johnson & Johnson MedTech/Abiomed Issued an URGETN MEDICAL DEVICE RECALL (REMOVAL) notice to its consignees on 05/18/2026 via UPS 1-day air delivery. The notice explained the reason for notification and potential patient impact Consignees were instructed to review all Impella CP Sets within inventory and quarantine affected units on hand, return all affected units using the provided return shipment label from Sedgwick, and complete and return the provided business response form. Upon receipt of returned product and completed BRF, Abiomed will provide a copy of a credit memo for the amount returned. Consignees were also instructed to forward the notification to anyone in each facility that needs to be informed and to post a copy of the notification in a visible area for awareness. If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice.
• Quantity in Commerce: 10 units
• Distribution: US distribution to GA, IA, NE, PA, TX, WA, WI. International distribution to Czech Republic, Norway, and Japan
• 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