Argyle 8888413815Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521004627), received between Apr 23, 2018 and Jan 18, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (5 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2024Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER WAS DEFECTIVE. IT WAS STATED THAT IT WAS LEAKING FROM A TINY CRACK IN THE EXTERNAL PORTION (EXIT SITE) OF THE DRAIN. THE CATHETER WAS NOT REPAIRED AND WAS REPLACED LATER IN THE SAME EVENING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18536745 ↗
• InjuryJan 5, 2024Break; Break

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER BROKE IN THE PATIENT'S ABDOMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18455743 ↗
• MalfunctionJun 4, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS NOT WORKING AND WAS NOT ADEQUATELY DRAINING THE DIALYSATE. THE CATHETER¿S COIL MOVED. IT WAS STATED THAT CATHETER WAS REPOSITIONED. IT WAS ALSO STATED THAT THE CATHETER DID NOT BREAK. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 11942355 ↗
• InjuryApr 20, 2021Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ACCORDING TO THE REPORTER, THE CATHETER WAS INSERTED ON (B)(6) 2020 AND REPOSITIONED ON (B)(6) 2020 AS THERE WAS PROBLEM WITH THE CATHETER NOT ADEQUATELY DRAINING THE DIALYSATE (THE PD WAS NOT WORKING, THE COIL MOVED BUT THE CATHETER DID NOT BREAK, IT WAS A FUNCTIONAL PROBLEM). THE PATIENT HAD A SMALL ABDOMINAL TRAUMA AT HOME IN (B)(6) 2020 (WITH HEMOPERITONEUM), THE PATIENT BANGED ON A CORNER OF A TABLE AND THERE WAS BLEEDING AROUND THE CATHETER AND THE PATIENT HAD 2 ABDOMEN SCANS. THE FIRST SCAN WAS ON (B)(6) 2020 FOLLOWING THE TRAUMA THAT WAS SHOWING A COLLECTION AROUND THE CATHETER (IN THE ABDOMINAL WALL). THE CATHETER WAS BROKEN DURING THIS SCAN BUT IT WAS NOT NOTICED WHEN READING THE SCAN. THE PATIENT HAD ANOTHER CONTROL SCAN ON (B)(6) 2020 (MOST PROBABLY BEFORE RESTARTING THE PERITONEAL DIALYSIS). THE SCAN THEN SHOWED THAT THE COLLECTION/HEMATOMA AROUND THE CATHETER (IN THE ABDOMINAL WALL) ALMOST DISAPPEARED. THE BROKEN PART OF THE CATHETER IS AT THE SAME LOCATION AS IN THE LAST SCAN, BUT WAS STILL NOT DETECTED W HEN READING THE SCAN. IN RETROSPECT, THEY REALIZED THAT THE CATHETER WAS ALREADY BROKEN AT THAT TIME (7 CM OF THE CATHETER LODGED ITSELF IN THE LEFT SUBDIAPHRAGMATI

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient; Hematoma; Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 11698061 ↗
• MalfunctionJul 25, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS, THE CATHETER WAS SECURED DURING EXTERNAL TRACTION AND GETTING WITHOUT DISTAL FOAM. THE BREAK OF THE CATHETER WAS FOUND AT THE DISTAL END(NEAR THE SKIN) WHICH MAKES THE CATHETER TO BURST AND MAKING ITS UNFEASIBLE. THE PROCEDURE WAS COMPLETED BUT THEY HAD TO EXTEND THE SURGICAL TIME OF 20 MINUTES DUE TO THE CATHETER REPLACEMENT. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO BLOOD LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8829176 ↗
• MalfunctionApr 23, 2018Break; Break

  ACCORDING TO THE REPORTER, POST LAPAROSCOPIC INSTALLATION OF CATHETER IN A FILTRATION, WHEN THE PATIENT CHANGED POSITION THEY NOTICED THAT THE DRESSING BECAME WET AND THERE WAS A LEAK. THEY STILL CONTINUED WITH THE THERAPY FOR SEVERAL DAYS BECAUSE OF FILTRATION REASONS. THEY TESTED THE CATHETER AND THEY CERTIFIED THAT THERE WAS A FISSURE APPROXIMATELY 1 CM AFTER THE SECOND CUFF NEAR THE RADIOPAQUE LINE. THEY SCHEDULED FOR ANOTHER LAPAROSCOPIC PROCEDURE TO REMOVE THE CATHETER, AND INSTALL A NEW ONE TO RESOLVE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7452490 ↗