FDA Device recall Z-1575-2013
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introduce…
- FDA Device
- Class I
- terminated
- Published 2013-07-03
On 2013-07-03 the FDA classified a Class I recall of Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introduce… by Medtronic Neuromodulation, citing the Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1575-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-06-03 |
| Published | 2013-07-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Contents of inner package are STERILE. The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port.
Reason
The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
Identifiers
| code_info | Product having a Use By Date prior to 25 Aug 2014 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1575-2013%22
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