CLASS II Device recall · Reported 2 Apr 2014 · FDA Enforcement Report
Fibernet Embolic Protection System recalled by Medtronic Vascular
Medtronic Vascular is recalling Fibernet Embolic Protection System: Recommended Vessel Diameter 5.0 -, Maximum Guidewire, distributed in Illinois, Louisiana, Massachusetts, Pennsylvania, Rhode Island, Virginia. The recall was initiated on 3 Mar 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1304-2014
- FDA event ID
- 67646
- Recalling firm
- Medtronic Vascular, Santa Rosa, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Mar 2014
- FDA classified
- 27 Mar 2014
- Reported
- 2 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 3 Mar 2014 | Recall initiated by company | |
| 27 Mar 2014 | Classified by FDA | +24 days |
| 2 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
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.
IllinoisLouisianaMassachusettsPennsylvaniaRhode IslandVirginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 67646This product is part of a recall event; the main page for the event is Fibernet Embolic Protection System recalled by Medtronic Vascular.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Fibernet Embolic Protection System recalled by Medtronic Vascular | Medtronic Vascular | Other | 6 states | |
| CLASS II | Fibernet Embolic Protection System recalled by Medtronic Vascular | Medtronic Vascular | Other | 6 states |
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