Home / Recalls / Cardiovascular Systems Inc / Z-2051-2016

Z-2051-2016 Class II Terminated

Recalled by Cardiovascular Systems Inc — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
July 6, 2016
Initiation Date
June 13, 2016
Termination Date
August 16, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
190 units (38 - 5 pack shelf cartons)

Product Description

ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360. Cardiovascular.

Reason for Recall

The pouch label was missing the use by date (UBD) of 2018-04.

Distribution Pattern

US Nationwide distribution.

Code Information

Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.

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-2386-2021 Class II — STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, RE (July 21, 2021)
  • Z-2385-2021 Class II — DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, (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-1771-2017 Class II — ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. S (March 3, 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)