FIBERNET Embolic Protection System: Recommended Vessel Diameter 6 — Class II medical device recall Z-1305-2014
Terminated recall by Medtronic Vascular, Inc., reported 2014-04-02, distributed in IL, LA, MA, PA, RI, VA. Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System (EPS) where
| Recall number | Z-1305-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2014-03-03 |
| Classified | 2014-03-27 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-06-03 |
| Distributed | IL, LA, MA, PA, RI, VA |
| Countries outside the US | DE, ES, IT, PL, RO, SA, SK |
| Lot numbers | 1E012916, 1E017817, 1E029750 |
| Model numbers | 600700190, FBN600700190 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1305-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.