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Argyle 8888411447Recalls & reported problems

Mozarc Medical US LLC · Peritoneal Dialysis Catheter, Tenckhoff, 2 Cuffs · Class 2 · Implant

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 10884521055476), received between Feb 22, 2019 and Feb 22, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Material Puncture/Hole” (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

  • Material Puncture/Hole1

Patient problems

  • Peritonitis1

Recent adverse event reports

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

  • InjuryFeb 22, 2019Material Puncture/Hole; Material Puncture/Hole

    ACCORDING TO THE REPORTER, POST OPERATIVELY, A CUSTOMER REPORTED THAT THERE WAS A SMALL HOLE IN THE CATHETER WHERE THE PERITONEAL CATHETER NEEDS TO BE CONNECTED (ON THE PATIENT SIDE OF THE CATHETER) ON THE SPOT WHERE THE LUER LOCK WAS ATTACHED ON THE CATHETER. IT WAS ALSO REPORTED THAT THIS WAS FORMED DUE TO THE FLEXION OF THE CATHETER AT THAT SPOT WHICH CAUSED THE HOLE. DUE TO THE LEAKAGE, PATIENT DEVELOPED PERITONITIS BUT WAS REPORTED TO BE DOING FINE. IT WAS STATED THAT 70% ALCOHOL WAS THE CLEANING AGENT USED, TEGO WAS NOT UTILIZED AND THE CATHETER WAS REPAIRED.

    Patient problems: Peritonitis

    MAUDE report 8364059 ↗

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.