FDA Medical Device Recalls (openFDA)
Medtronic Inc.: Medtronic SynchroMed, Model A10
- Recall number
- Z-0522-2024
- Recalling firm
- Medtronic Inc.
- Product
- Medtronic SynchroMed, Model A10
- Status
- Completed
- Initiated
- 2020-07-13
- Posted
- 2023-12-09
- Terminated
- not on file
- Reason
- 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
- 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
- 2543 units
- Distribution
- Foreign Distribution
- Lot, serial or model codes
- GTIN 00643169771031, All serial numbers with software version 1.1.300.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004"]
- Product code
- LKK
- Firm FEI
- 2182208
- Firm city
- Mounds View
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28