FDA Medical Device Recalls (openFDA)
Cardiovascular Systems Inc: ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
- Recall number
- Z-2051-2016
- Recalling firm
- Cardiovascular Systems Inc
- Product
- ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.
- Status
- Terminated
- Initiated
- 2016-06-13
- Posted
- not on file
- Terminated
- 2016-08-16
- Reason
- The pouch label was missing the use by date (UBD) of 2018-04.
- Root cause
- Process control
- Action
- Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.
- Quantity
- 190 units (38 - 5 pack shelf cartons)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
- 510(k) numbers
- ["K090521"]
- PMA numbers
- not on file
- Product code
- MCW
- Firm FEI
- 3004742232
- Firm city
- Saint Paul
- 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