FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: SynchroMed II Infusion Pump. Product Number: 8637-20
- Recall number
- Z-0137-2025
- Recalling firm
- Medtronic Neuromodulation
- Product
- SynchroMed II Infusion Pump. Product Number: 8637-20
- Status
- Open, Classified
- Initiated
- 2024-09-11
- Posted
- 2024-10-21
- Terminated
- not on file
- Reason
- Potential for error and inability to interrogate pump due to data corruption in the pump memory.
- Root cause
- Device Design
- Action
- On 11-September-2024, a Medtronic representative was sent to the physician s facility where the representative provided the communication and confirmation form to the physician. The physician was asked to sign the confirmation form indicating they read the notification. The representative reset the patient s pump.
- Quantity
- 1 unit
- Distribution
- US Nationwide distribution in the state of Mississippi.
- Lot, serial or model codes
- GTIN Number: 00643169630505. Serial Number: NGP004814H
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKK
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- 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