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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm July 13, 2020
Date Posted December 09, 2023
Recall Status1 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 2		 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 and Original Applicant = MEDTRONIC Inc.
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