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 and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Class I - DangerousWhat Should You Do?
- Check if you have this product: G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Additional Lots Identified: GV143 GV926 GV927 G13A00133 G13A00134 G13A01167 G13A01912 G13A00136 G13A00137 G13A01938
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Medtronic Vascular
- Reason for Recall:
- Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire. Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medt
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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 and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guide wires are not intended for cerebral vasculature. Medtronic steerable exchange guide wires are used to facilitate the substitution of one diagnostic or interventional device for another.
Product Codes/Lot Numbers:
G13A00130 G13A01300 GT414 GU543 GV117 GV118 GV121 GV381 GV382 GV919 GW768 Additional Lots Identified: GV143 GV926 GV927 G13A00133 G13A00134 G13A01167 G13A01912 G13A00136 G13A00137 G13A01938
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0264-2014
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