Z-2173-2008

Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the...

Name: Z-2173-2008 Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the...
Creator: Medtronic Neuromodulation
Published: 2008-04-14
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2008-04-14 / Terminated / root cause: design

FDA source

Medtronic Neuromodulation began a recall of Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to... on 2008-04-14. The reason FDA records is "The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2173-2008
Status: Terminated
Initiated: 2008-04-14
Posted: 2008-08-27
Terminated: 2008-09-10
Recalling firm: Medtronic Neuromodulation
Product: Model 8709SC Indura 1P One-Piece Intrathecal Catheter Medtronic Inc., Minneapolis, MN 55432 A part of the SynchroMed II Infusion system, which is designed to restore and provide intrathecal administration of drug therapy.
Product code: LKK Pump, Infusion, Implanted, Programmable
Reason for recall: The SC catheters cannot completely engage with the Model 700-04M portal connector. The result of this condition is a possible leakage or disconnect of the SC catheter from the portal during the continuous therapy trial period.
Root cause tag: design
FDA root cause: Device Design
Action: Medtronic informed all Belgium implanting and managing physicians of the SynchroMed II infusion system. Each customer was mailed a Dear Healthcare Professional letter (Medtronic Urgent: Field Safety Notice) on 4/3/08 providing important safety information and patient management recommendations regarding the device incompatibility. The firm recommends that healthcare professionals do not use SC catheters if a connection with an implantable access port is required. Also, if a continuous infusion trial is required with use of an implantable access port, they should use a model 8711 intrathecal catheter. The firm states that for patients who are currently undergoing a continuous trial with an implantable port, replacing the catheter connector before connecting to the SynchroMedd II using the Medtronic model 8578 revision kit is recommended. Medtronic also recommends discussing the risks of connection failure with patients. Local field reps will personally follow-up with affected customers to confirm and document notification.
Quantity in commerce: 232 total from all models
Distribution: International Distribution --- country of Belgium.
Product codes and lots: All lots numbers included

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)