Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Medtronic Vascular is recalling specific models of the ProVia Crossing Guidewire. The recall is due to a potential for the polytetrafluoroethylene (PTFE) coating to delaminate and detach from the guidewire. The affected models include 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, and 9PROV180SS.
These steerable guide wires are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature. They are not intended for use in the cerebral vasculature. The devices were distributed worldwide, including nationwide in the United States and in numerous international countries.
The source text does not specify the number of units affected or report any specific injuries or illnesses. Healthcare providers and consumers should verify if they possess these specific models and lot codes and follow instructions from the manufacturer or regulatory agencies regarding the return or disposal of the devices.
The recalled product
- Product
- ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary an
- Manufacturer
- Medtronic Vascular
- Category
- Medical Device — Cardiovascular
Distribution
Part of a larger recall action
This product is one of 8 recalled by Medtronic Vascular under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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