Argyle 8888411710Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Catheter, Curl Cath, 1 Cuff · Class 2 · Implant
All models of Argyle (36)
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 10884521004351), received between Jul 18, 2024 and Jul 18, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (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.
Reports received per month
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1
- Migration1
Patient problems
- Abdominal Pain1
- Bacterial Infection1
- Dyspnea1
- Erythema1
- Hypervolemia1
- Itching Sensation1
- Swelling/ Edema1
- Unintended Radiation Exposure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 18, 2024Insufficient Flow or Under Infusion; Migration; Insufficient Flow or Under Infusion; Migration
ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, HYPERTENSION, AND END-STAGE RENAL FAILURE WHO HAD PD (PERITONEAL DIALYSIS) TRAINING STARTED (B)(6) 2024, IN THE PATIENT'S HOME, CONTINUED FOR JUST OVER A WEEK BUT STOPPED AS THOUGH THE PATIENT THOUGHT TO HAVE AN ALLERGIC REACTION TO PD FLUID WITH SHORTNESS OF BREATH, SEVERE ITCH, FACIAL SWELLING, AND SEVERE SUPRAPUBIC PAIN ON DRAINING. THERE WAS FLUID OVERLOAD AND UREMIA DUE TO POOR PD FUNCTION. THE PD CATHETER ITSELF WAS NOT BEING BLAMED. ON DAY 1 OF TRAINING, THE PATIENT'S WIFE WAS ALSO PRESENT. THE PD CATHETER WAS WORKING WELL, WITH FLUID FLOWING IN AND OUT EASILY. THEY DID SOME FLUSHES, THEN THE PATIENT DID A MANUAL EXCHANGE, WHICH THEY MANAGED VERY WELL. THEY LEFT FLUID IN OVER LUNCHTIME, THEN IN THE AFTERNOON THEY SET UP THE MACHINE AND CONNECTED THE PATIENT ON FOR A TRIAL. THIS WENT WELL, DRAINING WELL, NO ALARMS, AND THE PATIENT WAS NOT EXPERIENCING ANY DRAIN PAIN. THEY WENT OVER THE THEORY, WHICH THE PATIENT AND WIFE PICKED UP REALLY EASILY. THE PATIENT GAINED A BIT OF BODY WEIGHT OVER THE CHRISTMAS PERIOD, HAD NO ISSUES WITH OEDEMA, AND CONTINUED TO PASS GOOD VOLUMES OF URINE. BP (BLOOD PRESSURE) WAS A B
Patient problems: Abdominal Pain; Bacterial Infection; Dyspnea; Erythema; Hypervolemia; Itching Sensation; Swelling/ Edema; Unintended Radiation Exposure; Uremia; Urticaria
MAUDE report 19774567 ↗
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