Argyle 8814661001Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Accessory,Beta-Cap Adapter · Class 2
All models of Argyle (36)
Data updated Oct 18, 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 10884521003972), received between Apr 20, 2018 and Dec 16, 2019 — classified as 2 malfunctions.
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 18, 2026.
Most reported problems
Device problems
- Break2
Patient problems
- No Information1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2019Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A SPONTANEOUSLY SPLIT CAUSING FLUID LEAK. THE HCP (HEALTHCARE PROFESSIONAL) USED ONLY SALINE ON THE EXIT SITE AND NO TRAUMA WAS NOTED. THE NURSE WAS THERE WHEN THE EVENT HAPPENED DURING DRAINAGE AND ANCHOR TAPE WAS USED. THE HCP REQUIRED A PROPHYLACTIC ANTIBIOTICS AND SURGICAL REMOVAL OF REMAINING PORTION OF CATHETER AND, A NEW ONE WAS INSERTED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Information
MAUDE report 9472888 ↗MalfunctionApr 20, 2018Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THEY OBSERVED A CRACK IN THE CAP WHEN THEY TIGHTENED IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7449018 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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