Flex-Neck® 00884450330067Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of Flex-Neck (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884450330067), received between Oct 14, 2020 and Sep 15, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Crack2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2021Crack; Crack
THE ACCOUNT ALLEGES THAT AFTER SUCCESSFUL IMPLANT THE PD CATHETER STARTED SHOWING SIGNS OF FATIGUE. MICRO-CRACKS APPEARED AT THE HUB END OF THE CATHETER, OUTSIDE PATIENT BODY. LIQUID WAS NOTED LEAKING FROM THE CATHETER. THE HOSE HAS BEEN SHORTENED BY MEDICAL PROFESSIONALS 3 TIMES THUS REMOVING THE CRACKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478341 ↗MalfunctionSep 15, 2021Crack; Crack
THE ACCOUNT ALLEGES THAT AFTER SUCCESSFUL IMPLANT THE PD CATHETER STARTED SHOWING SIGNS OF FATIGUE. MICRO-CRACKS APPEARED AT THE HUB END OF THE CATHETER, OUTSIDE PATIENT BODY. LIQUID WAS NOTED LEAKING FROM THE CATHETER. THE HOSE HAS BEEN SHORTENED BY MEDICAL PROFESSIONALS 3 TIMES THUS REMOVING THE CRACKED TUBING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12478338 ↗InjuryOct 14, 2020Fracture; Fracture
THE ACCOUNT ALLEGES THAT THE TUBING OF A PEDIATRIC PERITONEAL DIALYSIS CATHETER BROKE AFTER THE TUBING WAS DISCONNECTED WITH A PLASTIC CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10680962 ↗
Other Catheter, peritoneal, long-term indwelling devices
- Argyle 8811313010Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 death75 reports
- Aspira Drainage Kit 4992301Bard Access Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall4 reports
- Flex-Neck® 00884450170069Merit Medical Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
- Flex-Neck® 00884450305850Merit 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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