Data Foundry

Medical device recalls 2017

ViperWire Advance Peripheral Guide Wire with Flex Tip — Class II medical device recall Z-1771-2017

Terminated recall by Cardiovascular Systems Inc, reported 2017-04-19, distributed nationwide. Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because

Recall numberZ-1771-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCardiovascular Systems Inc, Saint Paul, MN, United States
Recall initiated2017-03-03
Classified2017-04-10
Reported by FDA2017-04-19
Terminated2017-11-28
DistributedNationwide (US)
Quantity186 devices
Lot numbers156032
Model numbersVPR-GW-FT18

Product

ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the device crown within peripheral arteries and provides a center of rotation for the device drive shaft. The guide wire torquer is a small, plastic accessory, packaged with the guide wire, and provides a gripping surface for manipulating the guide wire, if desired.

Reason for recall

Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip.

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-1771-2017. 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.