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Terminated

CORDIS SV-8 Steerable Guidewire, 300 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503658X

FDA Recall Z-1495-06 · Posted 2006-09-09

Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDXQ
Date Initiated2006-07-21
Date Terminated2008-11-19
Product Quantity740

Reason for Recall

Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.

Firm Action

A recall of all lots manufactured by the OEM was initiated by letter dated July 21, 2006. All lots of the SV-5 guidewire and related design SV-8 guidewire were placed on Stop Shipment 6/30/06.

Root Cause

Other

Distribution Pattern

World wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K930091CORDIS REFLEX STEERABLE GUIDEWIRECordis Corp. · 1993-04-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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