FDA Medical Device Recalls (openFDA)
Cardiovascular Systems, Inc.: 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 number
- Z-1250-2009
- Recalling firm
- Cardiovascular Systems, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2009-03-16
- Posted
- 2009-04-17
- Terminated
- 2012-04-20
- Reason
- 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.
- Root cause
- Incorrect or no expiration date
- 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.
- Quantity
- 10 devices
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot: P1406641
- 510(k) numbers
- ["K071427"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3004742232
- Firm city
- Arden Hills
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28