Argyle 8817278008Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Catheter Kit, Tenckhoff, 2 Cuffs · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521004276), received between Aug 6, 2018 and May 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Leak/Splash; Leak/Splash
ACCORDING TO THE REPORTER, DURING THE PROCEDURE (PATIENT USE) AT THE PATIENT HOME, WHEN THE PATIENT¿S SON JUST TURNED TO THE PATIENT (THE MOTHER), WHEN THE PATIENT NOTICED THE FLUID/LIQUID WAS LEAKING NEAR THE CATHETER (THE END OF CASSETTE UNIT BROKE/RUPTURED). IT WAS STATED THAT THE BARREL OF THE BAG MACHINE (MACHINE BAG PIPE) WAS LEAKING. THE SON TOOK IT OFF AND PUT THE CAP ON AND THEY DID NOT DO THE THERAPY THAT DAY. THE SON DID NOT TOUCH THE CATHETER, BUT IT GOT WET. IT WAS STATED THAT THE CATHETER HAS BEEN IN PLACED FOR 4 MONTHS AT THE TIME OF THE EVENT. THERE WAS NO DAMAGES/DEFECTS OBSERVED ON THE REPORTED CATHETER ITSELF. FLUSHING WAS DONE PRIOR TO USE AND THE RESULT WAS AUTOMATIC WASHING OF THE CASSETTE LINE. THE PATIENT WAS ALREADY CONNECTED WHEN THE EVENT OCCURRED. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. NO EXCESSIVE FORCE WAS USED ON THE DEVICE. THE CLEANING AGENT TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY WAS NEUTRAL/MILD LIQUID SOAP AND WATER. THE CLEANING AGENT TYPICALLY USED TO CLEAN THE CONNECTOR WAS W ATER AND NEUTRAL SOAP, DURING BATH. THE CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENT WAS NOT MIXED. THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16916886 ↗MalfunctionAug 6, 2018Break; Leak/Splash; Break
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THERE WAS LEAKAGE FROM THE PERITONEAL CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7751720 ↗
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® 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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