Medtronic Intrathecal Catheter — Class I medical device recall Z-1576-2013
Terminated recall by Medtronic Neuromodulation, reported 2013-07-03, distributed nationwide. The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for o
| Recall number | Z-1576-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2013-06-03 |
| Classified | 2013-06-25 |
| Reported by FDA | 2013-07-03 |
| Terminated | 2014-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, AW, BE, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HK, HU, IE, IL, IN, IS, IT, JO, KR, KW, LB, LK, LT, LU, MA, MT, NL, NO, NZ, PA, PL, PT, QA, RO, SA, SE, SG, SI, SK, TH, TR, TT, UY, VE, ZA |
| Quantity | 115,722 total |
| Reason classes | device malfunction |
| Model numbers | 8731SC |
Product
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package are STERILE. The implantable Medtronic Model 8731SC 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 8731SC catheter. The catheter connects to the pump at the catheter port.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1576-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.