Flex-Neck® 00884450330203Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450330203), received between Mar 30, 2021 and Mar 30, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Material Perforation” (1 report).
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
- Material Perforation1
Patient problems
- Bacterial Infection1
- Peritonitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2021Material Perforation; Material Perforation
THE ACCOUNT ALLEGES THAT DURING A DIALYSIS PROCEDURE, THE PERITONEAL DIALYSIS CATHETER TUBING WAS FOUND TO HAVE A SMALL PINHOLE IN THE END. THE MEDICAL STAFF CUT 5.5CM FROM THE EXIT POINT ON THE CATHETER TO REMOVE THE HOLE. THE PROCEDURE PROGRESSED NORMALLY. AN INFECTION "PERITONITIS" WAS IDENTIFIED AND THE PATIENT RECEIVED ANTIBIOTICS/MEDICAL INTERVENTION. THE PATIENT IS STILL USING THE PD CATHETER TODAY.
Patient problems: Bacterial Infection; Peritonitis
MAUDE report 11592455 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page