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

Recall Z-3077-2017 — Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicated for the removal of emboli and thrombi from native arteries or synthetic g

U.S. FDA — Device Enforcement · United States · 2017-07-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3077-2017
Date of alert: 2017-07-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 60439817

Reported risk: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.

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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