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U.S. Department of Health and Human Services

Class 2 Device Recall ViperWire Advance peripheral guide wire

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 Class 2 Device Recall ViperWire Advance peripheral guide wiresee related information
Date Initiated by FirmJune 13, 2016
Create DateJune 27, 2016
Recall Status1 Terminated 3 on August 16, 2016
Recall NumberZ-2051-2016
Recall Event ID 74445
510(K)NumberK090521 
Product Classification Catheter, peripheral, atherectomy - Product Code MCW
ProductViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
Code Information Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Recalling Firm/
Manufacturer		 Cardiovascular Systems Inc
1225 Old Hwy 8 NW
Saint Paul MN 55112-6416
For Additional Information ContactMegan Brandt
651-259-2805
Manufacturer Reason
for Recall		The pouch label was missing the use by date (UBD) of 2018-04.
FDA Determined
Cause 2		Process control
ActionConsignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.
Quantity in Commerce190 units (38 - 5 pack shelf cartons)
DistributionUS Nationwide distribution.
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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