Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm Recalled by Medtronic Vascular, Inc. Due to Medtronic is recalling a specific subset of lot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular, Inc. directly.
Affected Products
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic 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.
Quantity: 50 Total all sizes: 18 in US, 32 Internationally
Why Was This 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.
Where Was This Sold?
This product was distributed to 6 states: IL, LA, MA, PA, RI, VA
About Medtronic Vascular, Inc.
Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report