FDAJune 13, 2016device

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. Cardiova...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The pouch label was missing the use by date (UBD) of 2018-04.

What to do

FDA enforcement status: Terminated

Brands named

cardiovascular systemscardiovascular

UPCs

10852528005084

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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. Cardiova... — Recall Details · AllClear