FDAFDA · Food and drugs·Recall number Z-1304-2014
FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 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.
Published April 2, 2014 · Recall initiated: March 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Vascular, Inc.
- Distributor
- Worldwide Distribution - US including the states of IL, PA, MA, VA. RI and LA., and the countries of Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia and Spain.
- Lot
- US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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