Medtronic Sutureless Pump Connector Revision Kit — Class I medical device recall Z-1573-2013
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-1573-2013 |
|---|---|
| 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 | 8578, 8709, 8709SC |
Product
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required. The 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 an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector 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-1573-2013. 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.