Argyle 8810807001Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Accessory,Medical Grade Silicone Adhesive, Type A · Class 2
All models of Argyle (36)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521003927), received between Nov 14, 2022 and Dec 2, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2022Break; Break
ACCORDING TO THE REPORTER, THE PATIENT'S PERITONEAL DIALYSIS CATHETER WAS REPAIRED AGAIN AS THE JUNCTION THAT WAS PREVIOUSLY REPAIRED WITH GLUE/STICK DID NOT HOLD. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 15903807 ↗InjuryNov 14, 2022Break; Break
ACCORDING TO THE REPORTER, ON (B)(6) 2022, IN THE PEDIATRIC GASTROENTEROLOGY DEPARTMENT, A CHILD WAS ADMITTED TO HAVE HIS PERITONEAL DIALYSIS CATHETER REPAIRED (NEW) AS THE JUNCTION THAT HAD BEEN REPAIRED WITH GLUE/STICK ON (B)(6) 2022 DID NOT HOLD. THE CONSEQUENCE FOR THE PATIENT WAS THE RE-ADMISSION TO THE HOSPITAL. THERE WAS NO REPORTED FINAL PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 15788643 ↗
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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