FDA Medical Device Recalls (openFDA)
Merit Medical Systems, Inc.: Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
- Recall number
- Z-0866-2013
- 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.
- Status
- Terminated
- Initiated
- 2013-01-16
- Posted
- 2013-02-20
- Terminated
- 2015-09-16
- Reason
- A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization.
- 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
- 387 units
- Distribution
- Worldwide Distribution - USA including the states of NJ, FL, GA, MO, AZ, UT and the country of Denmark
- Lot, serial or model codes
- Lot numbers H399931S1; H411376; H399938S1; H411373; H399940S1; H411374; H399942S1; H411375; H399948S1; H411380; H399950S1; H411377; H39952S1; H411378; H39953S1; H411379.
- 510(k) numbers
- ["K121832"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1721504
- Firm city
- South Jordan
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28