Z-1304-2014Class II

FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter...

Name: Z-1304-2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm, Maximum Guidewire Diameter...
Creator: Medtronic Vascular, Inc.
Published: 2014-03-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-03-03 / Terminated / root cause: manufacturing process

FDA source

Medtronic Vascular, Inc. began a recall of 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... on 2014-03-03. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1304-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Posted: 2014-03-27
Terminated: 2014-06-03
Recalling firm: Medtronic, 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.
Product code: NTE Temporary Carotid Catheter For Embolic Capture
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.
Root cause tag: manufacturing process
FDA 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 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 [email protected], 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.
Product codes and lots: US Model Number FBC 500600190, lot number 1E029176; International Model Number FBN500600190, lot number 1E012914.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1304-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1303-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27
Z-1304-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27
Z-1305-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-27

Product code NTE

K082348Class IIFibernet Embolic Protection SystemLumen Biomedical, Inc. / cleared 2008-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)