Recalls / —

—#47238

Product

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 product code

DXQ — Blood Pressure Cuff

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K930091

Affected lot / code info

70905743 70905744 70905745 70206756 70206758 70206759 70306719 70306720 70306792 70306822 70306849 70406715 70406768 70406796 70506745 70506753 70506754 70506755

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 #47238. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.