ViperWire Advance Peripheral Guide Wire — Class II medical device recall Z-2051-2016
Terminated recall by Cardiovascular Systems Inc, reported 2016-07-06, distributed nationwide. The pouch label was missing the use by date (UBD) of 2018-04.
| Recall number | Z-2051-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2016-06-13 |
| Classified | 2016-06-27 |
| Reported by FDA | 2016-07-06 |
| Terminated | 2016-08-16 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10852528005084 |
| Lot numbers | 160877 |
| Model numbers | 72023-02, VPR-GW-17 |
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.
Reason for recall
The pouch label was missing the use by date (UBD) of 2018-04.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2051-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.