Reported Apr 2, 2014 · Terminated
FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in (…
Medtronic Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular, Inc. · 3576 Unocal Pl · Santa Rosa, CA · 95403-1774
Is this the product you have?
- FIBERNET Embolic Protection SystemRecommended Vessel Diameter 3.5 0 5.0 mm
- Maximum Guidewire Diameter0.014 in ( 0.36 mm) Rx only, Sterile
- Manufactured inInvatec S.P.A., Italy
- ManufacturerMedtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 mm to 7.0 mm
- Lot codes and dates
US Model Number FBC350500190lot number 1E029174Internation Model number FBN350500190lot 1E012912
- Amount recalled
- 50 total, all sizes: 18 in US, 32 Internationally.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where the yellow polyimide tube on the FIBERNET EPS was not removed from the FIBERNET EPS during the manufacturing process and subsequently may remain on the FIBERNET EPS.
This product could cause temporary or reversible health problems — stop using it.
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