ViperWire, Advance recallZ-2051-2016 · Cardiovascular Systems Inc · initiated Jun 13, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardiovascular Systems Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The pouch label was missing the use by date (UBD) of 2018-04.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2051-2016
- Status
- Terminated
- Initiated by the company
- Jun 13, 2016
- Recalling firm
- Cardiovascular Systems Inc
- Quantity
- 190 units (38 - 5 pack shelf cartons)
- Product code
- MCW
- FDA submissions
- K090521
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ViperWire, Advance VPR-GW-17Cardiovascular Systems, Inc. · Catheter, Peripheral, Atherectomy1 recall7 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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