FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.
- Recall number
- Z-1308-2008
- Recalling firm
- Medtronic Neuromodulation
- Product
- Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731 or 8731SC.
- Status
- Terminated
- Initiated
- 2008-01-09
- Posted
- 2008-07-22
- Terminated
- 2010-10-08
- Reason
- Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
- Root cause
- Packaging process control
- Action
- Consignees were notified by an Urgent Medical Device Recall letter sent in January 2008. The letter informed users that the recalling firm would contact them regarding removing the affected products from their inventory. Users were requested to return a response form indicating the number of affected product. For additional information, contact 1-800-707-0933.
- Quantity
- 18
- Distribution
- Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.
- Lot, serial or model codes
- Lot Numbers: N131154001, N131154003, N131154004, N131154008, N131154009, N131154010, N131154013, N131154016, N131154017, N130483001, N130483004, N130483006, N130483011, N130483012, N130483013, N130483014, N130483015 and N130483021.
- 510(k) numbers
- not on file
- PMA numbers
- ["P860004S081"]
- 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