Argyle 8811313013Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521004092), received between Aug 9, 2018 and Nov 12, 2020 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionNov 12, 2020Break; Break

  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: No Clinical Signs, Symptoms or Conditions; Peritonitis

  MAUDE report 10827732 ↗
• InjuryAug 9, 2018Break; Entrapment of Device

  ACCORDING TO THE REPORTER, THEY HAD A PERITONEAL DIALYSIS CATHETER IMPLANTED IN THEIR LOWER ABDOMEN FOR THE PURPOSE OF FACILITATING AND AUGMENTING NATURAL RENAL FUNCTION. AFTER APPROXIMATELY 21 MONTHS OF THE CATHETER BEING IMPLANTED IN THE PATIENT, THEY WERE ADVISED THAT THEIR NATURAL RENAL FUNCTION HAD RECOVERED AND THAT THE CATHETER COULD BE REMOVED. THE CATHETER WAS REMOVED BY THE SAME PHYSICIAN WHO PERFORMED THE IMPLANT PROCEDURE. FOR THE PROCEEDING YEARS, THE PATIENT INTERMITTENTLY EXPERIENCED DISCHARGE AND LEAKAGE OF BLOOD AND LIQUIDS FROM THE AREA WHERE THE CATHETER WAS REMOVED, WITH DIAGNOSES OF SKIN INFECTIONS, CELLULITIS WITH MICRO ABSCESS AND SLIGHT GROWTH OF (B)(6) FOR WHICH THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND TOPICAL TREATMENTS. THERE WAS THEN A DIAGNOSIS OF A RESOLVING CUTANEOUS ABSCESS ON THE ABDOMINAL WALL AND THE PATIENT WAS REFERRED TO A GENERAL SURGEON FOR REMOVAL OPTIONS DUE TO THE INCONVENIENCE OF HAVING TO WEAR A BANDAGE AT ALL TIMES. DURING THE EXCISION SURGERY A FOREIGN BODY WAS FOUND IN AND REMOVED FROM THE SITE, AND WAS LATER IDENTIFIED AS PART OF THE DIALYSIS CATHETER WHICH HAD BEEN IMPLANTED PREVIOUSLY.

  Patient problems: Abscess; Bacterial Infection; Cellulitis; Foreign Body In Patient; Foreign Body Reaction; Purulent Discharge; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 7767694 ↗