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U.S. Department of Health and Human Services

Class 2 Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tip

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 Class 2 Device Recall ViperWire Advance Peripheral Guide Wire with Flex Tipsee related information
Date Initiated by FirmMarch 03, 2017
Create DateApril 10, 2017
Recall Status1 Terminated 3 on November 28, 2017
Recall NumberZ-1771-2017
Recall Event ID 76784
510(K)NumberK151260 
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
ProductViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.
Code Information Lot 156032
Recalling Firm/
Manufacturer		 Cardiovascular Systems Inc
1225 Old Highway 8 NW
Saint Paul MN 55112-6416
Manufacturer Reason
for Recall		Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.
Quantity in Commerce186 devices
DistributionNationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
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 = MCW
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