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U.S. Department of Health and Human Services

Class 2 Device Recall FIBERNET Embolic Protection System:Recommended Vessel Diameter 3.5 0 5.0 mm

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  Class 2 Device Recall FIBERNET Embolic Protection System:Recommended Vessel Diameter 3.5 0 5.0 mm see related information
Date Initiated by Firm March 03, 2014
Date Posted March 27, 2014
Recall Status1 Terminated 3 on June 03, 2014
Recall Number Z-1303-2014
Recall Event ID 67646
510(K)Number K082348  
Product Classification Temporary Carotid Catheter for Embolic Capture - Product Code NTE
Product FIBERNET Embolic Protection System:
Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm)
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.
Code Information US Model Number FBC350500190, lot number 1E029174; Internation Model number FBN350500190; lot 1E012912.
Recalling Firm/
Manufacturer		 Medtronic Vascular, Inc.
3576 Unocal Pl
Santa Rosa CA 95403-1774
For Additional Information Contact Carlos Alfonso
763-526-2513
Manufacturer 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.
FDA Determined
Cause 2		 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 RADAR # 174028 to initiate a return and credit of product. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com, or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of the potentially affected product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. lf any FIBERNET EPS within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We apologize for the inconvenience this may cause you; please be assured that patient safety and product quality remain our primary concern. Should you have any questions, please contact your Medtronic representative or Medtronic LifeLine Technical Services at 1 (877) 526-7890 or (+1 763) 526-7890.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NTE and Original Applicant = LUMEN BIOMEDICAL, INC.
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