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U.S. Department of Health and Human Services

Class 2 Device Recall CORDIS Peripheral Steerable Guidewire

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 Class 2 Device Recall CORDIS Peripheral Steerable Guidewiresee related information
Date Initiated by FirmJuly 21, 2006
Date PostedSeptember 09, 2006
Recall Status1 Terminated 3 on November 19, 2008
Recall NumberZ-1493-06
Recall Event ID 35940
510(K)NumberK930091 
Product Classification Peripheral Steerable Guidewire - Product Code DXQ
ProductCORDIS-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
Code Information 70905743 70905744 70905745 70206756 70206758 70206759 70306719 70306720 70306792 70306822 70306849 70406715 70406768 70406796 70506745 70506753 70506754 70506755
Recalling Firm/
Manufacturer		 Cordis Corporation
14201 NW 60th Ave
Miami Lakes FL 33014-2802
Manufacturer Reason
for Recall		Tip separation-Cordis SV-5 and SV-8 Steerable Guidewires may have a potential for guidewire fracture resulting in tip separation.
FDA Determined
Cause 2		Other
ActionA 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.
Quantity in Commerce480
DistributionWorld wide Distribution-USA and Japan, Canada, Panama, Peru, Puerto Rico, Uruguay, Mexico and The Netherlands
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DXQ
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