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Permcath 8888169001Recalls & reported problems

Mozarc Medical US LLC · Chronic Silicone Oval Catheter Repair Kit Staggered Tip · Class 2 · Implant

All models of Permcath (7)

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 10884521009929), received between Aug 11, 2021 and Aug 11, 2021 — 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

Patient problems

  • Unintended Radiation Exposure2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 11, 2021Break; Break

    ACCORDING TO THE REPORTER, 2 YEARS AFTER IMPLANTATION, THE CATHETER WAS TOO FLOPPY AND IT WAS VERY DIFFICULT TO REMOVE, THE CUFF WAS STUCK. TO AVOID THE CATHETER BREAKING OFF IN THE PATIENT, A SMALL INCISION WAS MADE AND THE CUFF WAS SLOWLY DISSECTED AWAY FROM THE CHEST WALL. A SLIGHT TEAR CAN BE NOTED ON THE CATHETER AT THE CUFF WHICH WOULD HAVE BROKEN OFF. THERE WAS NO PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

    MAUDE report 12308096 ↗
  • InjuryAug 11, 2021Break; Break

    ACCORDING TO THE REPORTER, BLUNT DISSECTION WAS DONE TO REMOVE THE CATHETER'S CUFF BUT IT WAS UNSUCCESSFUL AFTER MULTIPLE ATTEMPTS. THE CATHETER WAS SAID TO BE VERY FLOPPY AND DIFFICULT TO REMOVE. THE DISTAL END OF THE CATHETER WAS INADVERTENTLY SEVERED AND THE PROXIMAL END OF THE CATHETER WAS CLAMPED WITH A HEMOSTAT. IT WAS SAID THAT THE PATIENT WAS THEN TRANSFERRED TO THE INTERVENTIONAL RADIOLOGY LABORATORY AND THE PATIENT'S NECK AND CHEST WAS THEN RE-PREPPED IN STERILE FASHION. FLUOROSCOPIC IMAGING REVEALED A SHEARED THOUGH INTACT TUNNELED DIALYSIS CATHETER. NEXT, SMALL INCISION WAS MADE SUPERIOR TO THE INSERTION SITE AND BY USING A SHARP AND BLUNT DISSECTION, THE CATHETER WAS FREED AND SUBSEQUENTLY REMOVED. MANUAL PRESSURE WAS HELD OVER THE RIGHT INTERNAL JUGULAR VEIN AREA UNTIL HEMOSTASIS WAS ACHIEVED. THE SMALL INCISION WAS CLOSED WITH 3-0 VICRYL SUTURE. THE PATIENT LEFT THE INTERVENTIONAL RADIOLOGY LABORATORY IN STABLE CONDITION.

    Patient problems: Unintended Radiation Exposure

    MAUDE report 12307872 ↗

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Sources and updates

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