Z-0866-2013Class II

Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage...

Name: Z-0866-2013 Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage...
Creator: Merit Medical Systems, Inc.
Published: 2013-01-16
License: https://open.fda.gov/license/

Merit Medical Systems, Inc. / initiated 2013-01-16 / Terminated / root cause: manufacturing process

FDA source

Merit Medical Systems, Inc. began a recall of Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system on 2013-01-16. FDA classified it as Class II and gives the reason as "A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0866-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-16
Posted: 2013-02-20
Terminated: 2015-09-16
Recalling firm: Merit Medical Systems, Inc.
Product: Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Merit initiated the recall on January 16, 2013. A voicemail script notification to users and Q&A document was provided to those sales representative that had received and or distributed product. On January 16, 2013, Merit sales representatives began contacting each physician and/or user facility that had been provided product. Written communication distribution began on 22 January 2013. Affected sales representatives, physicians, and hospitals were provided written identification information, instruction to not distribute or continue placing these devices, and on how to return any unused product if applicable. All product on hand at Merit was inventoried and remains under quarantined status. Further questions please call (801) 208-4301,
Quantity in commerce: 387 units
Distribution: Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
Product codes and lots: Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-27	2013-02-20

Product code FGE

K121832Class IIResolve Biliary Locking Drainage CatheterMerit Medical Systems, Inc. / cleared 2012-07-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)