CLASS II Device recall · Reported 19 Apr 2017 · FDA Enforcement Report

ViperWire Advance Peripheral Guide Wire with Flex Tip recalled

Cardiovascular Systems is recalling ViperWire Advance Peripheral Guide Wire with Flex Tip, distributed nationwide in the US. The recall was initiated on 3 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 156032

Quantity recalled186 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1771-2017
FDA event ID: 76784
Recalling firm: Cardiovascular Systems, Saint Paul, MN
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2017
FDA classified: 10 Apr 2017
Reported: 19 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

3 Mar 2017	Recall initiated by company
10 Apr 2017	Classified by FDA	+38 days
19 Apr 2017	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA

Nationwide Arkansas Arizona Colorado Florida Georgia Hawaii Indiana Kansas Kentucky Louisiana Mississippi North Carolina New Mexico Rhode Island Texas Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot 156032

Where was it sold?

Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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