FDA Device recall Z-1305-2014
FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile
- FDA Device
- Class II
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class II recall of FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm, Maximum Guidewire Diameter: 0.014 in (0.36mm) Rx only, Sterile by Medtronic Vascular, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1305-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-03-03 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Vascular |
| Distribution | IL, LA, MA, PA, RI, VA |
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.
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.
Identifiers
| code_info | US Model Number FBC 600700190, lot number 1E029750; International Model Number: FBN600700190: lot numbers 1E012916, 1E017817. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1305-2014%22
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