Medtronic Vascular, Inc. Recall: FIBERNET Embolic Protection System: Recommended Vessel Di
Medtronic Vascular, Inc. Recall: FIBERNET Embolic Protection System: Recommended Vessel Di is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Medtronic Vascular, Inc.; Product: FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter: 0.014 i
| Recalling firm | Medtronic Vascular, Inc. |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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. |
| Recall initiated | 20140303 |
| Recall number | Z-1304-2014 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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