Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1305-2014 — 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 indicated for use as

U.S. FDA — Device Enforcement · United States · 2014-03-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1305-2014
Date of alert: 2014-03-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Vascular, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 600700190

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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