Class 2 Device Recall SynchroMed II Infusion Pump

• Date Initiated by Firm: September 11, 2024
• Date Posted: October 21, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0137-2025
• Recall Event ID: 95419
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: SynchroMed II Infusion Pump. Product Number: 8637-20
• Code Information: GTIN Number: 00643169630505. Serial Number: NGP004814H
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Jeff Trauring; 763-760-0001
• Manufacturer Reason for Recall: Potential for error and inability to interrogate pump due to data corruption in the pump memory.
• FDA Determined Cause: Device Design
• Action: On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.
• Quantity in Commerce: 1 unit
• Distribution: US Nationwide distribution in the state of Mississippi.
• 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.