Flex-Neck® 00884450170199Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450170199), received between May 28, 2020 and Nov 30, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Fracture2
- Material Perforation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 30, 2021Fracture; Material Perforation; Fracture; Material Perforation
THE ACCOUNT ALLEGES THAT POST PD CATHETER PLACEMENT, THE CATHETER BECAME DAMAGED AND DETACHED WITHIN THE PATIENT. PLACEMENT WAS COMPLETED IN OCTOBER WITHOUT ANY CONCERNS. ADMISSION WAS NECESSARY 4 WEEKS POST IMPLANT PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12902235 ↗InjuryMay 28, 2020Fracture; Fracture
THE ACCOUNT ALLEGES THAT POST-PERITONEAL DIALYSIS CATHETER PLACEMENT; THE PATIENT PRESENTED WITH AN INFECTION AT TIME OF CATHETER REMOVAL. THE PHYSICIAN STATES THAT THE CATHETER IMPLANT SITE WAS LIKELY THE CAUSE OF THE INFECTION. MEDICAL INTERVENTION FOR THE INFECTION WAS NECESSARY. DURING THE CATHETER REMOVAL THE DERMAL CUFF DETACHED WITHIN THE PATIENT RECTUS MUSCLE. THE PHYSICIAN ADMINISTERED ADDITIONAL ANESTHETIC FOR PATIENT COMFORT, AND THE FOREIGN BODY WAS SURGICALLY REMOVED. THE PATIENT TOLERATED THE PROCEDURE WELL WITH NO OTHER CONSEQUENCES TO REPORT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10096993 ↗
Other CATHETER, PERITONEAL, LONG-TERM INDWELLING devices
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- Flex-Neck® 00884450305850Merit Medical Systems, Inc. · Catheter, peritoneal, long-term indwelling1 recall0 reports
- Flex-Neck® 00884450170069Merit Medical Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
- Argyle 8888415604Mozarc Medical US LLC · Catheter, peritoneal, long-term indwelling48 reports
- Argyle 8888423103Mozarc Medical US LLC · Catheter, Peritoneal, Long-Term Indwelling42 reports
- Argyle 8888411405Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING33 reports
- Argyle 8888413807Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING16 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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