Cardiovascular Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-2051-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 13, 2016

Date Posted: July 6, 2016

Recall Number: Z-2051-2016

Event ID: 74445

Reason for Recall:

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

Status: Terminated

Product Quantity: 190 units (38 - 5 pack shelf cartons)

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated