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U.S. Department of Health and Human Services

Class 2 Device Recall Diamondback 360, CSI ViperWire

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 Class 2 Device Recall Diamondback 360, CSI ViperWiresee related information
Date Initiated by FirmMarch 16, 2009
Date PostedApril 17, 2009
Recall Status1 Terminated 3 on April 20, 2012
Recall NumberZ-1250-2009
Recall Event ID 51499
510(K)NumberK071427 
Product Classification Peripheral Catheter Atherectomy - Product Code MCW
ProductDiamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system.
Code Information Lot: P1406641
FEI Number 3004742232
Recalling Firm/
Manufacturer		 Cardiovascular Systems, Inc.
651 Campus Dr
Arden Hills MN 55112-3495
For Additional Information Contact
651-259-1600
Manufacturer Reason
for Recall		CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
FDA Determined
Cause 2		Incorrect or no expiration date
ActionCustomer letters were FedEx'd to CSI Sales Professionals on 03/16/2009, who delivered the letters and helped coordinate the removals of affected product. The letter identified the product, provided a description of the issue and provided instructions to immediately remove from use and return the affected guidewires to CSI. A Customer Acknowledgement Form was asked to be completed and returned with the devices.
Quantity in Commerce10 devices
DistributionNationwide 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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