—#47237

Product

CORDIS SV-5 Steerable Guidewire, 180 cm., 5 Steerable Guidewires, Cordis a Johnson Johnson Company, ENDOVASCULAR, Manufactured for: Cordis Corporation, Miami, FL 33102-5700. USA, Catalog # 503558.

FDA product code: DXQ — Blood Pressure Cuff
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K930091
Affected lot / code info: 70206754 70206755 70206760 70306717 70306718 70306754 70306771 70306791 70306821 70306848 70406714 70406739 70406767 70506775

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Cordis Corporation
Address: 14201 NW 60th Ave, Miami Lakes, Florida 33014-2802

Distribution

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

Timeline

Recall initiated: 2006-07-21
Posted by FDA: 2006-09-09
Terminated: 2008-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #47237. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.