Z-2051-2016Class II

ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model...

Name: Z-2051-2016 ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model...
Creator: Cardiovascular Systems Inc
Published: 2016-06-13
License: https://open.fda.gov/license/

Cardiovascular Systems Incorporated / initiated 2016-06-13 / Terminated / root cause: manufacturing process

FDA source

Cardiovascular Systems Inc began a recall of 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... on 2016-06-13. FDA classified it as Class II and gives the reason as "The pouch label was missing the use by date (UBD) of 2018-04". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2051-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-13
Posted: 2016-06-27
Terminated: 2016-08-16
Recalling firm: Cardiovascular Systems Incorporated
Product: 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 code: MCW Catheter, Peripheral, Atherectomy
Reason for recall: The pouch label was missing the use by date (UBD) of 2018-04.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were sent on 6/13/16 a Cardiovascular Systems, Inc. "Urgent Correction" letter date June 10, 2016. The letter described the problem and the affected product. Advised consignees to set affected product aside for their sales representative which will be applying the correct pouch label to the affected product. Requested consignees to fill and sign the Customer Acknowledgement Form that the sales representative will be presenting to them. For questions contact Quality at Cardiovascular Systems, Inc. 1-651-259-2068 1225 Old Highway 8 NW Saint Paul, MN 55112.
Quantity in commerce: 190 units (38 - 5 pack shelf cartons)
Distribution: US Nationwide distribution.
Product codes and lots: Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2051-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2051-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-27

Product code MCW

K090521Class IIDiamondback 360 DbxCardiovascular Systems, Inc. / cleared 2009-03-20

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)