Recall Z-1304-2014— Medtronic Vascular, Inc.

Name: FDA recall Z-1304-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-03

Class II · Terminated

Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2014-03-03, terminated 2014-06-03. It names one FDA 510(k) clearance: K082348. Product: 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.. 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..

Recalling firm: Medtronic Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Terminated: 2014-06-03
Firm location: Santa Rosa, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K082348 — FIBERNET EMBOLIC PROTECTION SYSTEMLumen Biomedical, Inc.·cleared 2008-11-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.