Argyle 8888423111Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521056862), received between Dec 10, 2021 and Mar 22, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING ASSISTED PERITONEAL DIALYSIS, AFTER CONNECTING THE TUBE, THE TUBE WAS BROKEN AND WATER LEAKAGE WAS FOUND. IT WAS STATED THAT THE PATIENT HAD PERITONITIS BEFORE SURGERY AND CONTINUED TO RECEIVE TREATMENT AFTER SURGERY. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. FLUSHING WAS DONE WITH NORMAL RESULT. THE LEAKING PART OF THE CATHETER WAS CUT OFF AND RECONNECTED FOR TEMPORARY USE AS REMEDIAL ACTION AND INTERVENTION/TREATMENT PROVIDED AS A RESULT OF THE LEAKING. THE PRODUCT WAS NOT REPLACED. HOWEVER, THE EXTERNAL PART WAS SHORT AND WILL NEED ANOTHER SURGERY TO REPLACE THE TUBE. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. PATIENT WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETERS. THERE WAS NO BLOOD TRANSFUSION REQUIRED. THE PATIENT WAS UNDERGOING TREATMENT AND IN STABLE CONDITION. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 18963465 ↗
• MalfunctionFeb 21, 2024Break; Break

  ACCORDING TO THE REPORTER, AFTER IMPLANTATION, A BROKEN LEAK WAS NOTED IN THE MIDDLE OF THE CATHETER (CATHETER SHAFT). THERE WAS NO LEAK AT THE CONNECTION BETWEEN THE BIFURCATION AND THE CATHETER. THERE WAS NO PROBLEM WITH THE LUER ADAPTER. THE REPORTED PRODUCT WAS NOT REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18748337 ↗
• MalfunctionJan 17, 2024Break; Manufacturing, Packaging or Shipping Problem; Break; Manufacturing, Packaging or Shipping Problem

  ACCORDING TO THE REPORTER, BEFORE SURGERY, THE PIPE WAS OPENED AND FOUND TO BE DAMAGED. IT WAS NOTED THAT THE OUTER PACKAGING HAS BEEN OPENED AND MUST BE DAMAGED. IT WAS ALSO SAID THAT THE CATHETER END TRACHOMA WAS THE PART OF THE CATHETER THAT WAS HAVING ISSUES. THE CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WAS NO EXCESSIVE FORCE USED ON THE PRODUCT. A CLEANING AGENT WAS NOT USED ON THE DEVICE. AS A REMEDIAL ACTION, THE PRODUCT WAS REPLACED WITH OTHER TUBES. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM AFTER REMEDIAL ACTION WAS DONE. THERE WAS NO INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18528375 ↗
• MalfunctionDec 10, 2021Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE PLACEMENT OF CATHETER PROCESS, IT WAS FOUND THAT THERE WAS A CRACK OR HOLE IN THE CATHETER'S BODY DURING PRE-FILLING. THEY OPENED A NEW SET OF CATHETER AS THE INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE LEAKAGE, THE PRO CEDURE WAS PROCEEDED AND COMPLETED. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE, THERE WAS NO MEDICAL INTERVENTION DONE TO THE PATIENT, THERE WAS NO OTHER PRODUCT UTILIZED WITH THE DEVICE, THERE WAS NO DAMAGE TO THE DEVICE'S EXTERNAL PACKAGING AND BOX. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT AND THE CATHETER THAT CAME WITH THE KIT WAS THE ONE USED. THE CATHETER WAS NOT REPAIRED, THERE WAS A LEAK AT THE CATHETER'S BODY, THERE WAS NO CLEANING AGENT USED ON THE DEVICE, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975571 ↗