Argyle 8888411009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521004313), received between May 25, 2021 and Jan 13, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Break; Break

  ACCORDING TO THE REPORTER, AFTER 2 MONTHS AND 29 DAYS AFTER THE PERITONEAL DIALYSIS CATHETER WAS INSERTED LAPAROSCOPICALLY, THE NEPH ROLOGIST SAW THAT THE PD CATHETER WAS BROKEN. THE CATHETER WAS EXPLANTED THE DAY AFTER. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163795 ↗
• InjuryMay 26, 2021Migration or Expulsion of Device; Infusion or Flow Problem; Migration or Expulsion of Device; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED 23RD APRIL, AND CATHETER WAS DISPLAYING OUTFLOW FAILURE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED 11 DAYS AFTER WHICH IDENTIFIED PERITONEAL ADHESION AND GREATER OMENTAL WRAPPING AND THESE BLOCKED THE SIDEHOLES. THE CATHETER WAS STRIPPED FROM THE OMENTUM AND REPOSITIONED IN THE DOUGLAS PERITONEAL SAC AND FLUSHED SEVERAL TIMES. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, SURGICAL SIEVE AND TITANIUM ADAPTER WERE UTILIZED WITH THE DEVICE. THE CATHETER WAS REPAIRED, TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND THE STANDARD PROCESS WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. IT WAS STATED THAT THE DEVICE WAS EVENTUALLY EXPLANTED AND REPLACED WITH A DIFFERENT SUPPLIER¿S DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11885544 ↗
• InjuryMay 25, 2021Migration or Expulsion of Device; Infusion or Flow Problem; Migration or Expulsion of Device; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, THE CATHETER WAS IMPLANTED ON (B)(6) OF JANUARY AND WAS DISPLAYING OUTFLOW FAILURE. A LAPAROSCOPIC PROCEDURE WAS PERFORMED 10 DAYS AFTER WHICH THEY IDENTIFIED PERITONEAL ADHESION AND GREATER OMENTAL WRAPPING WHICH BLOCKED THE SIDEHOLES, WITH ¿PLIERS¿ THEY TOOK OMENTUM AWAY TO MAKE THE CATHETER FREE. AFTER CATHETER WAS FREE, THEY FLUSHED THE CATHETER WITH A SALINE SOLUTION TO REOPEN THE SIDEHOLES AGAIN. THE CATHETER WAS STRIPPED FROM THE OMENTUM AND REPOSITIONED IN THE DOUGLAS PERITONEAL SAC AND FLUSHED SEVERAL TIMES TO RESOLVE THE ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, AND SURGICAL SIEVE AND TITANIUM ADAPTER WERE UTILIZED WITH THE DEVICE. THE CATHETER WAS REPAIRED, TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE PROCEDURE WAS COMPLETED, THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT AND THE STANDARD PROCESS WAS USED TO TREAT THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11880255 ↗