Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1877-2017 — 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

U.S. FDA — Device Enforcement · United States · 2017-02-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1877-2017
Date of alert: 2017-02-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cardiovascular Systems Inc
Product category: device
Product type: Devices

Reported risk: CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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