Diamondback 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.
FDA Recall Z-1250-2009 · Posted 2009-04-17
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Recalling FirmCardiovascular Systems, Inc.
Recall StatusTerminated
Product CodeMCW
Date Initiated2009-03-16
Date Terminated2012-04-20
Product Quantity10 devices
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.
Firm Action
Customer 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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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