Recall Z-1304-2014 ยท NTE Temporary Carotid Catheter For Embolic Capture
Medtronic Vascular, Inc.
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 wh
| Date | Mar 27, 2014 (initiated Mar 3, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Manufacturing material removal |
| Action | Medtronic sent an Urgent Device Recall letter dated March 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records show that your facility has received one or more of these FIBERNET EPS, as shown in the attachment to this notification. Consequently, Medtronic requests you immediately take the following actions: 1. Immediately remove and quarantine all potentially affected product that remains in your inventory. 2. Return these units to Medtronic. Contact Customer Service at 1-888- 283-7868 and reference RA |
| Quantity | 50 Total all sizes: 18 in US, 32 Internationally. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082348 | FIBERNET EMBOLIC PROTECTION SYSTEM Lumen Biomedical, Inc., Nov 18, 2008 |