Device product
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.
Z-1305-2014
Product summary
- Event
- Event 67646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 Total all sizes: 18 in US, 32 Internationally
- Official record key
device-enforcement:Z-1305-2014
Official wording
Reason: 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.
Code information: US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817.
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.