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.
What this means for you
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 involves a medical device with a manufacturing defect where a component may remain on the device. The source text does not report any illnesses or injuries, fitting the rubric 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 affects the 6.0-7.0 mm recommended vessel diameter model, which is indicated for use as a guidewire and emboli protection system in carotid arteries.
The recall was initiated because the yellow polyimide tube on the FIBERNET EPS was not removed from the device during the manufacturing process. Consequently, this tube may remain on the FIBERNET EPS. The affected units are sterile and prescription-only.
The recall covers 50 total units across all sizes, with 18 units distributed in the US and 32 units distributed internationally. US distribution included Illinois, Pennsylvania, Massachusetts, Virginia, Rhode Island, and Louisiana. International distribution included Germany, Italy, Poland, Romania, Saudi Arabia, Kosovo, Slovakia, and Spain. Affected US units are Model Number FBC 600700190, lot number 1E029750. Affected international units are Model Number FBN600700190, lot numbers 1E012916 and 1E017817.
The recalled product
- Product
- FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 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
- Manufacturer
- Medtronic Vascular, Inc.
- Category
- Medical Device — Cardiovascular
- Hazard
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 FBC 600700190
- lot number 1E029750
- International Model Number: FBN600700190: lot numbers 1E012916
- 1E017817.
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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