CLASS II Device recall · Reported 3 May 2017 · FDA Enforcement Report
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire recalled
Cardiovascular Systems is recalling ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, distributed nationwide in the US. The recall was initiated on 9 Feb 2017 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-1877-2017
- FDA event ID
- 76928
- Recalling firm
- Cardiovascular Systems, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Feb 2017
- FDA classified
- 25 Apr 2017
- Reported
- 3 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 9 Feb 2017 | Recall initiated by company | |
| 25 Apr 2017 | Classified by FDA | +75 days |
| 3 May 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
Where it was distributed
US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMichiganMinnesotaMissouriMississippi
Questions about this recall
Why was it recalled?
CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018 in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
Which lots are affected?
Lot #: 175069, 175070, 176255
Where was it sold?
US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA
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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