CORDIS-SV-5 Steerable Guidewire, 300 cm.,5 Steerable Guidewires,Cordis a Johnson Johnson Company ,ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA., Catalog # 503558X
FDA Recall Z-1493-06 · Posted 2006-09-09
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Recalling FirmCordis Corporation
Recall StatusTerminated
Product CodeDXQ
Date Initiated2006-07-21
Date Terminated2008-11-19
Product Quantity480
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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