Home / Recalls / Cardiovascular Systems Inc / Z-1771-2017

Z-1771-2017 Class II Terminated

Recalled by Cardiovascular Systems Inc — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
April 19, 2017
Initiation Date
March 3, 2017
Termination Date
November 28, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
186 devices

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.

Distribution Pattern

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

Code Information

Lot 156032

Other recalls by Cardiovascular Systems Inc

  • Z-0394-2022 Class I — WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval Cat (November 22, 2021)
  • Z-2385-2021 Class II — DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, (July 21, 2021)
  • Z-2386-2021 Class II — STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, RE (July 21, 2021)
  • Z-3021-2018 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 13, 2018)
  • Z-0506-2018 Class II — Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-0505-2018 Class II — Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy system (September 14, 2017)
  • Z-2122-2017 Class II — CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Numbe (April 14, 2017)
  • Z-1877-2017 Class II — ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7 (February 9, 2017)
  • Z-1230-2017 Class II — DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Orbit (December 7, 2016)
  • Z-2051-2016 Class II — ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only (June 13, 2016)