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

Recall Z-1019-2013 — Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage: The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or

U.S. FDA — Device Enforcement · United States · 2013-03-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1019-2013
Date of alert: 2013-03-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Inc. Cardiac Rhythm Disease Management
Product category: device
Product type: Devices

Reported risk: Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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