CLASS II Device recall · Reported 6 Jul 2016 · FDA Enforcement Report
ViperWire Advance Peripheral Guide Wire, Sterilized recalled
Cardiovascular Systems is recalling ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, distributed nationwide in the US. The recall was initiated on 13 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2051-2016
- FDA event ID
- 74445
- Recalling firm
- Cardiovascular Systems, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jun 2016
- FDA classified
- 27 Jun 2016
- Reported
- 6 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 13 Jun 2016 | Recall initiated by company | |
| 27 Jun 2016 | Classified by FDA | +14 days |
| 6 Jul 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The pouch label was missing the use by date (UBD) of 2018-04.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
The pouch label was missing the use by date (UBD) of 2018-04.
Which lots are affected?
Lot #160877, UDI Number: (01)10852528005084(17)180430(10)160877.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardiovascular Systems
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Wirion Embolic Protection System, Delivery Catheter recalled | Cardiovascular Systems | Other | 37 states |
| Device | CLASS II | Stealth 360 Gen2 Peripheral Orbital Atherectomy System Micro recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | Diamondback 360 Gen2 Peripheral Orbital Atherectomy System Solid recalled | Cardiovascular Systems | Labeling Errors | Nationwide |
| Device | CLASS II | CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump recalled | Cardiovascular Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Peripheral Diamondback 1.25 Solid OAD recalled by Cardiovascular Systems | Cardiovascular Systems | Other | 9 states |
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| Device | CLASS II | Pipeline Flex Embolization Device with Shield Technology recalled | Micro Therapeutics | Labeling Errors | Nationwide |
| Device | CLASS II | System (RED 62 Reperfusion Catheter) recalled by Penumbra | Penumbra | Device Malfunction | Nationwide |
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