Z-0614-2014Class II

Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including...

Name: Z-0614-2014 Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including...
Creator: Merit Medical Systems, Inc.
Published: 2013-12-06
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2013-12-06 / Terminated / root cause: packaging

FDA source

Merit Medical Systems, Inc. began a recall of Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the... on 2013-12-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0614-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-06
Posted: 2013-12-31
Terminated: 2014-01-27
Recalling firm: Merit Medical Systems, Inc.
Product: 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.
Product code: KRA Catheter, Continuous Flush
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Merit Medical Systems sent an Urgent Product Recall Notice dated December 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of the Maestro Microcatheters identified and isolate them in a quarantined area until the product is over-labeled by their Merit Sales Representative Customers were instructed to ensure that all personnel to whom the devices were distributed were made aware of the field action. Customers with questions were instructed to contact their sales representative or call 1-801-826-4062. For questions regarding this recall call 801-253-1600.
Quantity in commerce: 59
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada.
Product codes and lots: Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0614-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0614-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-08	2013-12-31

Product code KRA

K082613Class IIMerit MicrocatheterMerit Medical Systems, Inc. / cleared 2008-12-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)