ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire — Class II medical device recall Z-1877-2017
Terminated recall by Cardiovascular Systems Inc, reported 2017-05-03, distributed nationwide. CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discov
| Recall number | Z-1877-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiovascular Systems Inc, Saint Paul, MN, United States |
| Recall initiated | 2017-02-09 |
| Classified | 2017-04-25 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-07-27 |
| Distributed | Nationwide (US) |
| Quantity | 595 |
| Lot numbers | 175069, 175070, 176255 |
| Model numbers | 7-10026-01, VPR-GW-FT14 |
Product
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1877-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.