FDA Device recall Z-2051-2016
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only
- FDA Device
- Class II
- terminated
- Published 2016-07-06
On 2016-07-06 the FDA classified a Class II recall of ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only by Cardiovascular Systems, citing the pouch label was missing the use by date (UBD) of 2018-04.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2051-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-06-13 |
| Published | 2016-07-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Cardiovascular Systems |
| Distribution | US |
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
The pouch label was missing the use by date (UBD) of 2018-04.
Identifiers
| code_info | Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Other recalls by Cardiovascular Systems
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FDA Device · Class I · 2021-12-29 · Cardiovascular Systems - DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
FDA Device · Class II · 2021-09-08 · Cardiovascular Systems - CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000
FDA Device · Class II · 2018-09-19 · Cardiovascular Systems - Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive at…
FDA Device · Class II · 2018-02-14 · Cardiovascular Systems
All Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2051-2016%22
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