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Argyle 8888425702Recalls & reported problems

Mozarc Medical US LLC · Peritoneal Dialysis Catheter,Oreopoulos-Zellerman Curl Cath, 1 Cuff, 1 Bubble,63 cm · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521056015), received between Mar 12, 2019 and Mar 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 12, 2019Fluid/Blood Leak; Fluid/Blood Leak

    ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAK. IT WAS REPORTED THAT THE PATIENT CAME TO THE EMERGENCY ROOM WHERE THE CATHETER WAS SURGICALLY REMOVED AND A NEW ONE WAS PLACED ON THE OPPOSITE SIDE OF THE ABDOMEN. THERE WAS NO INFORMATION ON THE CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO BLOOD LOSS AND NO TRANSFUSION WAS DONE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8415003 ↗

Other Catheter, Peritoneal, Long-Term Indwelling devices

All Catheter, Peritoneal, Long-Term Indwelling devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.