Recalls / —
—#204258
Product
Medtronic SynchroMed, Model A10
- FDA product code
- LKK — Pump, Infusion, Implanted, Programmable
- Device class
- Class 3
- Medical specialty
- Unknown
- PMA numbers
- P860004
- Affected lot / code info
- GTIN 00643169771031, All serial numbers with software version 1.1.300.
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.
Root cause (FDA determination)
Software Design Change
Action the firm took
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.
Recalling firm
- Firm
- Medtronic Inc.
- Address
- 8200 Coral Sea St Ne, Mounds View, Minnesota 55112-4391
Distribution
- Distribution pattern
- Foreign Distribution
Timeline
- Recall initiated
- 2020-07-13
- Posted by FDA
- 2023-12-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #204258. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.