Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect
Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the device is a high-risk medical product used in carotid artery procedures. No injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Vascular, Inc. is recalling specific lot numbers of the FIBERNET Embolic Protection System (EPS). The recall is due to a manufacturing defect where the yellow polyimide tube on the device was not removed during the production process and may remain on the system.
The FIBERNET EPS is indicated for use as a guidewire and emboli protection system to capture and remove embolic material during percutaneous transluminal interventional procedures in carotid arteries. The affected units are sterile and prescription-only. The recall covers 50 total units, with 18 distributed in the United States and 32 distributed internationally.
Distribution includes the US states of Illinois, Pennsylvania, Massachusetts, Virginia, Rhode Island, and Louisiana, as well as Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia, and Spain. The specific US model number is FBC350500190 (lot 1E029174) and the international model number is FBN350500190 (lot 1E012912). Healthcare providers should contact Medtronic for further instructions regarding the affected devices.
The recalled product
- 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…
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- US Model Number FBC350500190
- lot number 1E029174
- Internation Model number FBN350500190
- lot 1E012912.
Distribution
Part of a larger recall action
This product is one of 3 recalled by Medtronic Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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