FDA Medical Device Recalls (openFDA)
Medtronic Inc, Neurological & Spinal Division: Synchromed II infusion pump
- Recall number
- Z-1040-04
- Recalling firm
- Medtronic Inc, Neurological & Spinal Division
- Product
- Synchromed II infusion pump
- Status
- Terminated
- Initiated
- 2004-05-11
- Posted
- 2004-07-20
- Terminated
- 2005-11-23
- Reason
- The opposite version serial numbers were assigned to 20mL and 40mL SynchroMed II Model 8637 pumps. This size-type indication is used by the programmer to identify the pump size and can cause a limitation in the useable fill volume on a 40 mL pump and could cause some confusion related to the size of a 20 mL pump which identifies itself as a 40 mL pump.
- Root cause
- Other
- Action
- The physicians have been notified via letter of the problem with the pump. Appointments will be made with the patients and a Medtronic representative to correct the implanted devices.
- Quantity
- 14
- Distribution
- Within the United States and outside the United States.
- Lot, serial or model codes
- Serial numbers: NGP002428N, NGP002429N, NGP002430N, NGP002436N, NGP002437N, NGP002447N, NGP002448N, NGP002495N, NGV001296N, NGV001335N, NGV001390N, NGV001391N, NGV001433N, NGV001447N
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004/060"]
- Product code
- FRN
- Firm FEI
- 2182207
- Firm city
- Columbia Heights
- 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