Recall Z-1771-2017— Cardiovascular Systems Inc

Name: FDA recall Z-1771-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Class II · Terminated

Class II FDA medical device recall by Cardiovascular Systems Inc, initiated 2017-03-03, terminated 2017-11-28. It names one FDA 510(k) clearance: K151260. 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: 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..

Recalling firm: Cardiovascular Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-03
Terminated: 2017-11-28
Firm location: Saint Paul, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K151260 — ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADCardiovascular System, Inc.·cleared 2015-06-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.