Z-1415-06

Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal...

Name: Z-1415-06 Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal...
Creator: Medtronic Neurological
Published: 2006-07-21
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2006-07-21 / Terminated

FDA source

Medtronic Neurological began a recall of Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter)... on 2006-07-21. The reason FDA records is "Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1415-06
Status: Terminated
Initiated: 2006-07-21
Posted: 2006-09-09
Terminated: 2007-06-21
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Intrathecal Catheter Distal Revision Kit, Model 8598, (provides replacement parts for the distal section of the 8731 Intrathecal Catheter) . Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.
FDA root cause: Other
Action: An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.
Quantity in commerce: Recalls Z-1414-1415-06-USA- 359 devices. - Foreign 575 devices
Distribution: Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom
Product codes and lots: Model 8598 Base Lot Numbers: B011468N, B011893N, B011894N, N0012129, N0012612, N0012969, N0012970, N0012971, N0014057, N0014058, N0014179, N0014180, N0016472. *Model 8731 Catheters and model 8598 Distal Revision kits have a Base Lot number of eight (8) characters plus a two (2) digit suffix that represents serialization within these recalled lots. This list provides just the Base lot Number (the first eight characters of the product Lot No. found on the product labeling).

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)