Argyle 8815677001Recalls & reported problems
Mozarc Medical US LLC · Pediatric Peritoneal Dialysis, Catheter Curl Cath, 1 Preperitoneal Cuff · Class 2 · Implant
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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521004207), received between Nov 12, 2020 and Nov 20, 2020 — classified as 2 injuries.
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
- Insufficient Device Problem Information1
Patient problems
- Peritonitis2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2020Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A SPLIT (LIKE A CUT) WHERE THE ADAPTER CONNECTS THE TRANSFER SET TO THE PATIENT SIDE WHICH WAS NOTICED DUE TO A LEAK NOTED BY THE PATIENT'S PARENT. THE CATHETER WAS REPAIRED. THE PATIENT DEVELOPED PERITONITIS AND WAS ADMITTED TO THE HOSPITAL FOR TWO WEEKS. THE PATIENT REQUIRED ANTIBIOTICS.
Patient problems: Peritonitis
MAUDE report 10875383 ↗InjuryNov 12, 2020Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A SPLIT WHERE THE ADAPTER CONNECTS THE TRANSFER SET TO THE PATIENT SIDE. THERE WAS NO PATIENT INJURY.
Patient problems: Peritonitis
MAUDE report 10827744 ↗
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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