Medtronic SynchroMed, Model A10 recallZ-0522-2024 · Medtronic Inc. · initiated Jul 13, 2020
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software Design Change
What the company is doing
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.
Recall details
- Recall number
- Z-0522-2024
- Status
- Completed
- Initiated by the company
- Jul 13, 2020
- Posted by the FDA
- Dec 9, 2023
- Recalling firm
- Medtronic Inc.
- Quantity
- 2543 units
- Product code
- LKK
- FDA submissions
- P860004
- Distribution
- Foreign Distribution
Product description
Medtronic SynchroMed, Model A10
Code information (models, lots, serial numbers)
GTIN 00643169771031, All serial numbers with software version 1.1.300.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/A A810Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall0 reports
Other devices under the same FDA submission
50 devices cleared under P860004 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall7 deaths4,929 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls5 deaths4,303 reports
- SYNCHROMED ® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths4,119 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls10 deaths3,054 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths3,084 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 recalls1 death2,588 reports
- SynchroMed® II 8637-40Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall6 deaths2,291 reports
- SYNCHROMED® II 8637-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall3 deaths2,242 reports
- SYNCHROMED® II 8637-40Medtronic, Inc. · Pump, infusion, implanted, programmable1 recall4 deaths1,964 reports
- SynchroMed® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE1 recall4 deaths1,920 reports
- SYNCHROMED™ III 8667-20Medtronic, Inc. · Pump, infusion, implanted, programmable1 death1,937 reports
- SYNCHROMED ® II 8637-20Medtronic, Inc. · PUMP, INFUSION, IMPLANTED, PROGRAMMABLE2 deaths1,766 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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