Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 — recall Z-1573-2013

U.S. FDA — Device Enforcement · United States · 2013-06-03 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1573-2013
Date of alert: 2013-06-03
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Neuromodulation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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