Z-1771-2017Class II

ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide...

Name: Z-1771-2017 ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide...
Creator: Cardiovascular Systems Inc
Published: 2017-03-03
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2017-03-03 / Terminated

FDA source

Cardiovascular Systems Inc began a recall of 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... on 2017-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1771-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Posted: 2017-04-10
Terminated: 2017-11-28
Recalling firm: Cardiovascular Systems Incorporated
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.
Product code: MCW Catheter, Peripheral, Atherectomy
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.
FDA root cause: Under Investigation by firm
Action: Customers were sent an Urgent Medical Device Recall letter beginning March 03, 2017. The letter identified affected product, reason for recall, and asked for affected devices to be removed from use and return to CSI. Questions can be directed to CSI Customer Service at 877-274-0901, or your CSI Sales Representative.
Quantity in commerce: 186 devices
Distribution: Nationwide distribution in the states of AR, AZ, CO, FL, GA, HI, IN, KS, KY, LA, MS. NC, NM, RI, TX, VA
Product codes and lots: Lot 156032

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1771-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1771-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-19	2017-04-10

Product code MCW

K151260Class IIViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADCardiovascular System, Inc. / cleared 2015-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)