Z-1308-2008

Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number...

Name: Z-1308-2008 Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number...
Creator: Medtronic Neuromodulation
Published: 2008-01-09
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2008-01-09 / Terminated / root cause: packaging

FDA source

Medtronic Neuromodulation began a recall of Medtronic Intrathecal Catheter Pump Segment Revision Kit; Programmable implanted infusion pump; Model Number: 8596SC; Packaged with catheter model number 8731... on 2008-01-09. The reason FDA records is "Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1308-2008
Status: Terminated
Initiated: 2008-01-09
Posted: 2008-07-22
Terminated: 2010-10-08
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.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Incorrect Connector Pin: The Medtronic 8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the incorrect connector pin.
Root cause tag: packaging
FDA 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 in commerce: 18
Distribution: Nationwide Distribution including states of MI, OR, IN, NY, FL, PA, MN, TX, CO and UT.
Product codes and lots: Lot Numbers: N131154001, N131154003, N131154004, N131154008, N131154009, N131154010, N131154013, N131154016, N131154017, N130483001, N130483004, N130483006, N130483011, N130483012, N130483013, N130483014, N130483015 and N130483021.

Product code LKK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)