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U.S. Department of Health and Human Services

Class 2 Device Recall Runthrough NS Guidewire

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 Class 2 Device Recall Runthrough NS Guidewiresee related information
Date Initiated by FirmJune 03, 2011
Date PostedJuly 20, 2011
Recall Status1 Terminated 3 on July 27, 2011
Recall NumberZ-2858-2011
Recall Event ID 59051
510(K)NumberK063695 
Product Classification Wire, guide, catheter - Product Code DQX
ProductRunthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Transluminal Coronary Angioplasty (PTCA) and/or Percutaneous Transluminal Angioplasty (PTA)
Code Information Lot 101028, exp 2013 - 09
Recalling Firm/
Manufacturer		 Terumo Medical Corporation
950 Elkton Blvd
Elkton MD 21921-5322
For Additional Information ContactKathleen Little, PhD
800-283-7866 Ext. 7123
Manufacturer Reason
for Recall		Baloon catheter guidewires may become uncoiled during angioplasty procedures.
FDA Determined
Cause 2		Device Design
ActionTerumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.
Quantity in Commerce70 units
DistributionNationwide (USA) Distribution -- including the states of: CT, GA, and SC.
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 = DQX
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