FDAFebruary 9, 2017device
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 th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
cardiovascular systemscardiovascular
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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