Medtronic Vascular, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1303-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) 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.

Product Classification:

Class II

Date Initiated: March 3, 2014

Date Posted: April 2, 2014

Recall Number: Z-1303-2014

Event ID: 67646

Reason for Recall:

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.

Status: Terminated

Product Quantity: 50 total, all sizes: 18 in US, 32 Internationally.

Code Information:

US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.

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.

Voluntary or Mandated:

Voluntary: Firm initiated