Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

ViperWire Advance Peripheral Guide Wire Recalled by Cardiovascular Systems Inc Due to The pouch label was missing the use by...

Date: June 13, 2016
Company: Cardiovascular Systems Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cardiovascular Systems Inc directly.

Affected Products

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.

Quantity: 190 units (38 - 5 pack shelf cartons)

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Cardiovascular Systems Inc

Cardiovascular Systems Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report