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.
Recall
- Recall Number
- Z-1250-2009
- Event Number
- 51499
- Firm
- Cardiovascular Systems, Inc.
- FEI Number
- 3004742232
- Product Code
- MCW
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- March 16, 2009
- Posted
- April 17, 2009
- Terminated
- April 20, 2012
- Address
- 651 Campus Dr, Arden Hills, MN, 55112-3495
Description
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.
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.
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.
Nationwide Distribution
10 devices