Class 2 Device Recall Medtronic

• Date Initiated by Firm: July 13, 2020
• Date Posted: December 09, 2023
• Recall Status: Completed
• Recall Number: Z-0522-2024
• Recall Event ID: 93401
• PMA Number: P860004
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: Medtronic SynchroMed, Model A10
• Code Information: GTIN 00643169771031, All serial numbers with software version 1.1.300.
• Recalling Firm/ Manufacturer: Medtronic Inc.; 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer Reason for Recall: The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
• FDA Determined Cause: Software Design Change
• Action: Medtronic issued a SAFETY NOTIFICATION to its consignees on 07/13/2020 by letter. The notice explained the problem with the device and requested the software be upgraded to version 1.1.342.
• Quantity in Commerce: 2543 units
• Distribution: Foreign Distribution
• 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.

• PMA Database: PMAs with Product Code = LKK