Reported Jan 8, 2014 · Terminated

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and…

Merit Medical Systems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc. · 1600 West Merit Parkway · South Jordan, UT · 84095

Is this the product you have?

  • 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 materials into vessels.
Lot codes and dates
  • Catalog Numbers28MC24110ST
  • with Lot NumberH548211
  • and Catalog Number28MC24130SN
  • with Lot Numbers
    • H549598
    • or H553237
Amount recalled
59

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 27, 2014 · Data as of Sep 19, 6:15 PM UTC

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