Argyle 8888413823Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521004634), received between Jun 30, 2020 and Mar 28, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

• MalfunctionMar 28, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, IT WAS OBSERVED THAT THE CATHETER WAS LEAKING WHEN IT WAS TAKEN OUT FROM THE PATIENT AS PER THE SURGEON. IT WAS STATED THAT THE PERITONEAL DIALYSIS CATHETER (PDC) HAD THE SECONDARY STRUCTURAL FAILURE, NUMEROUS PINHOLE LEAKS. AS A REMEDIAL AND INTERVENTION, THE CATHETER WAS REMOVED DURING THE FOLLOW-UP SURGERY. THE PRODUCT WAS NOT REPLACED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 21726330 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE CATHETER WAS PLACED ON THE LEFT SIDE OF THE PATIENT¿S ABDOMEN. DURING A DIALYSIS CATHETER REMOVAL, IT WAS CONFIRMED TO BE A PD CATHETER. THE DOCTOR SHOWED THE REMOVED CATHETER, AND BOTH CUFFS WERE MISSING. IT WAS STATED THAT THE CUFFS HAD BEEN ATTACHED TO THE CATHETER CANNULA. BOTH VERIFIED THAT THE DEVICE WAS NOT EXPIRED. A DISCUSSION WAS HAD BETWEEN THE DOCTORS ON HOW INVASIVE IT WOULD BE TO REMOVE THE CUFFS. THE PATIENT HAD NOT CONSENTED TO GENERAL ANESTHESIA. THEY WERE ABLE TO RETRIEVE ONE CUFF THROUGH THE EXISTING INCISION BUT NOT THE SECOND, AS THE PATIENT WAS BECOMING UNCOMFORTABLE WHILE SEARCHING TO FIND IT. THEY DECIDED TO LEAVE THE SECOND CUFF AND END THE PROCEDURE. THE CUFF THAT WAS REMOVED APPEARED TO BE INTACT, AND IT REQUIRED SOME CUTTING TO BE REMOVED FROM THE TISSUE. THERE WAS MINIMAL BLOOD LOSS DURING THE PROCEDURE, AND IT WAS REPORTED TO BE 5 ML OF BLOOD LOSS. NO X-RAY WAS PERFORMED. IT WAS STATED THAT THE DEVICE WAS EASILY EVACUATED; THERE WAS NO TENSION. IT WAS ALSO STATED THAT NO PORTION OF THE CUFF REMAINED ON THE CATHETER. NO OTHER DAMAGE WAS NOTED OTHER THAN THE MISSING CUFFS. THE REASON FOR THE REMOVAL OF THE DEVICE WAS THAT I

  Patient problems: Foreign Body In Patient

  MAUDE report 20039821 ↗
• MalfunctionMay 23, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING INSERTION PROCEDURE, A PIECE WHICH WAS CLEAR PLASTIC RING OF THE PD (PERITONEAL DIALYSIS) CATHETER BROKE OFF. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS TREATED PRIOR TO PRODUCT PLACEMENT. NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. IT WAS SOAKED IN NORMAL SALINE. THE RESULT OF FLUSHING PRIOR TO USE WAS NORMAL. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. NO CLEANING AGENT USED ON THE DEVICE. NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT. THE INSERTION SITE WAS PREPPED WITH HIBICLENS PRIOR TO PRODUCT PLACEMENT. THE PRODUCT WAS NEVER IMPLANTED. PHYSICIAN WAS ABLE TO REMOVE PIECES IMMEDIATELY VIA LAPAROSCOPIC GRASPER AND REPLACE IT WITH A NEW PD CATHETER. THE PROCEDURE WAS COMPLETED AFTER RESOLVING THE ISSUE. THERE WAS NO BLOOD LOSS. BLOOD TRANSFUSION WAS NOT REQUIRED. NO MEDICAL INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THE PATIENT TREATED UNDER GENERAL ANESTHESIA AND THE ANESTHESIA TIME WAS NOT EXTENDED BY GREATER THAN 30 MINUTES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387902 ↗
• MalfunctionMar 23, 2021Break; Break

  ACCORDING TO THE REPORTER, A LEAK HAD DEVELOPED NEAR TO CATHETER EXIT SITE WHERE A CRACK OBSERVED OVER A YEAR AFTER INSERTION. THE CATHETER WAS NOT REPAIRED. POVIDONE IODINE WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS CLEANSED WITH IODINE PRIOR TO PRODUCT PLACEMENT. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THE TREATMENT WAS BY PRESCRIPTION. BACTROBAN OINTMENT WAS UTILIZED AS THE EXIT SITE. ADHESIVE DRESSING CALLED COSMOPORE WAS USED AS THE WOUND DRESSING AND IT DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA AND PRIOR TO APPLYING OINTMENT TO THE AREA. THE PATIENT WAS RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE AND WOULD DO DAILY PD CATHETER EXIT SITE DRESSING WITH IODINE SWABSTICK. THE CLEANING AGENT HAD NEVER SWITCHED OVER THE LIFE OF THE CATHETER AND IT HAD NEVER MIXED. THE SITE HAD NEVER USED SEPSIDERM TO CLEAN CATHETERS. THERE WAS NO PROTOCOL CHANGE FOR CLEANING AGENT USED RECENTLY. THE PATIENT THEMSELVES WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC ON THE CATHETERS. FLUSHING WAS DON

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

  MAUDE report 11558926 ↗
• MalfunctionFeb 16, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING USE, IT WAS STATED THAT THE PATIENT HAD A DRAINAGE PROBLEM DUE TO THE CATHETER. THE CAREGIVERS PRESCRIBED A FLUCTUATING MODALITY TO THE PATIENT IN ORDER TO ALLEVIATE THESE DRAINAGE PROBLEMS. IT WAS STATED THAT THE LINES ARE NOT PINCHED, STUCK OR BLOCKED AND WAS IN THE RIGHT PLACE OF THE ABDOMEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11331418 ↗
• InjuryJun 30, 2020Break; Break

  ACCORDING TO THE REPORTER, WHEN THE CATHETER WAS IMPLANTED IN THE PATIENT, THERE WERE NO ANY COMPLICATIONS AND THE PATIENT WAS RELEASED FROM THE HOSPITAL. APPROXIMATELY TWO (2) WEEKS LATER, WHEN THE PATIENT RETURNED FOR A FOLLOW-UP VISIT, THE CATHETER WAS NOT ABLE TO BE FLUSHED WHEN REGULAR HEPARIN WAS INFUSED. IT WAS ALSO STATED THAT CONTRAST POOLED WAS NOTED IN THE SUBCUTANEOUS TISSUE. WHEN THEY FAILED TO LOCATE THE DISTAL END OF THE CATHETER, A CT (COMPUTED TOMOGRAPHY) SCAN WAS ORDERED. IT REVEALED THAT THE CATHETER WAS BROKEN INTO TWO PIECES AND THE PATIENT WAS TAKEN INTO THE SURGERY TO REMOVED THE BROKEN DEVICE.

  Patient problems: Foreign Body In Patient; Radiation Exposure, Unintended; Unintended Radiation Exposure

  MAUDE report 10211317 ↗