PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 8, 2014 Initiated: December 6, 2013 #Z-0614-2014

Product Description

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.

Reason for Recall

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.

Details

Units Affected
59
Distribution
Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Location
South Jordan, UT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Merit Medical Systems, Inc.. Units affected: 59.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2014. Severity: Moderate. Recall number: Z-0614-2014.

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