Recall Z-1250-2009
Cardiovascular Systems, Inc. · initiated March 16, 2009
Product
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.
Codes / lots: Lot: P1406641
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: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1250-2009
- Initiated
- March 16, 2009
- Posted by FDA
- April 17, 2009
- Terminated
- April 20, 2012
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Quantity
- 10 devices
- Distribution
- Nationwide Distribution
- Recalling firm
- Cardiovascular Systems, Inc., Arden Hills, MN