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

Recall Z-0614-2014 — Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic

U.S. FDA — Device Enforcement · United States · 2013-12-06 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0614-2014
Date of alert: 2013-12-06
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Merit Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match.

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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