Class 2 Device Recall Medtronic SynchroMed

• Date Initiated by Firm: January 09, 2025
• Date Posted: April 01, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1506-2025
• Recall Event ID: 96237
• PMA Number: P860004
• Product Classification: Pump, infusion, implanted, programmable - Product Code LKK
• Product: A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
• Code Information: version v.2x, UDI/DI 00763000632793
• FEI Number: 2182207
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Naomi Rodiles; 763-514-2000
• Manufacturer Reason for Recall: Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
• FDA Determined Cause: Under Investigation by firm
• Action: Medtronic issued an URGENT: MEDICAL DEVICE correction notice to its consignees on 02/28/2025 via email or US mail. The notice explained the issue and provided recommendations to temporarily mitigate the problem, and requested the following: Actions " Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records. " Please provide a copy of the attached patient letter to your affected patients. " Please complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. For questions regarding this communication, please contact Medtronic Technical Services at 1-800-707-0933 or your local Medtronic representative.
• Quantity in Commerce: 4365 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
• 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 = LKK