Argyle 8888411702Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10884521004337), received between Sep 8, 2017 and Apr 3, 2024 — classified as 3 injuries, 5 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2024Misassembled; Detachment of Device or Device Component; Misassembled; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, TO FACILITATE THE IMPLANTATION OF THE PD (PERITONEAL DIALYSIS) CATHETER LAPAROSCOPICALLY, IT WAS PLACED IN THE ABDOMEN VIA A TROCAR AND THEN GUIDED RETROGRADELY THROUGH THE ABDOMINAL WALL VIA A TUNNELED ABDOMINAL WALL CHANNEL CREATED BY THE INTENDED EXIT SITE ON THE RECTUS SHEATH POSTERIOR WALL USING LAPAROSCOPIC OVERHOLT VIA A PERITONEAL MINIPERFORATION CREATED IN THE LOWER ABDOMEN. THE CATHETER WAS THEN CORRECTED BY PULLING FROM THE OUTSIDE IN A POSITION THAT ALLOWED BOTH CATHETER SLEEVES TO LIE RETROPERITONEALLY. THE CATHETER CORRECTION WAS ONLY POSSIBLE WITH INCREASED TRACTION AND A TIGHT ABDOMINAL WALL. AFTER POSITION CORRECTION OR WHEN THE CATHETER WAS PLACED CORRECTLY, A FREE FLUSHING OF THE CATHETER WAS NOT POSSIBLE, SO IT HAD TO BE REMOVED AGAIN. AFTER PULLING TOWARDS THE ABDOMEN, THE VISIBLE DISTAL SLEEVE OR OUTSIDE CUFF WAS DETACHED FROM THE CATHETER SHAFT, WHICH COULD BE RECOVERED DURING CATHETER REMOVAL. THE PROXIMAL SLEEVE OR THE INNER SIDE CUFF WAS ALSO REMOVED WHICH COULD NOT BE RECOVERED DURING CATHETER REMOVAL. A NEW PD CATHETER WITH NORMAL FUNCTION COULD THEN BE IMPLANTED USING THE SAME PROCEDURE. THE CATHETER SLEE

  Patient problems: Foreign Body In Patient

  MAUDE report 19033639 ↗
• MalfunctionAug 16, 2022Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE CATHETER HAD A CRACK. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15237431 ↗
• MalfunctionAug 16, 2022Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, THE CATHETER HAD A CRACK. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15237406 ↗
• MalfunctionAug 16, 2022Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE REPORTER, THE CATHETER HAD A CRACK. THERE WAS NO REPORTED PATIENT OUTCOME.

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

  MAUDE report 15237374 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS, THE CUSTOMER STATED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION BY CATHETER. THE CUSTOMER INDICATED THAT THE CATHETER WAS PLACED ON (B)(6) 2022 BUT ON FIRST SIGNS APPEARED ON (B)(6) 2022 WITH BILATERAL ERYTHEMA OF THE LOWER LIMBS THEN IT BECAME WIDESPREAD, SO PD (PERITONEAL DIALYSIS) WAS EVENTUALLY DISCONTINUED AND THE CATHETER REMOVED". THE CUSTOMER CONFIRMED THAT IT WAS NOT ABOUT THE DEVICE WHICH WAS REPORTED AS MATERIOVIGILANCE.

  Patient problems: Erythema

  MAUDE report 15058790 ↗
• InjuryDec 30, 2020Break; Break

  ACCORDING TO THE REPORTER, MORE THAN A MONTH AFTER THE PERITONEAL DIALYSIS (PD) CATHETER WAS PLACED IN THE OPERATING ROOM (OR), THERE WAS LEAKAGE AT THE EXTERNAL PART OF THE CATHETER AT THE TIME OF THE DIALYSIS TREATMENT. TWO MILLIMETER (MM) SLITS WERE FOUND ON THE CATHETER. IT WAS MENTIONED THAT THE CATHETER WAS SHORTENED (A CUT RESPECTING A STERILE PROCESS AND WAS CONNECTED TO THE TITANIUM ADAPTER) TO REMOVE THE DEFECT IN THE CATHETER AND RESOLVE THE ISSUE. THE PATIENT HAD STAPHYLOCOCCUS EPIDERMIDIS PERITONITIS AND ANTIBIOTIC THERAPY (WAS GIVEN INTRAPERITONEALLY). A REPAIR KIT WAS NOT USED AND BETADINE WAS USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THE TREATMENT USED (MUPIROCIN) WAS BY PRESCRIPTION AND DERMAL BETADINE OR SCRUB WAS USED TO CLEAN THE CATHETER IN ITS ENTIRETY. MUPIROCIN WAS ALSO UTILIZED AT THE EXIST SITE AND STERILE COMPRESSES ARE UTILIZED IS AS WOUND DRESSING. THE WOULD DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES AND THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER AND WERE NEVER MIXED. SEPSIDERM WAS NEVER USED TO CLEAN THE CATHETERS AND TH

  Patient problems: Peritonitis

  MAUDE report 11095548 ↗
• MalfunctionSep 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING THE FIRST DAY OF DIALYSIS, THERE WAS LEAK OBSERVED ON THE CATHETER SHAFT. IT WAS A HOLE, THE SIZE OF A PINHEAD AND NOT ASSOCIATED WITH A CUT. IT WAS REPORTED THAT THE CATHETER WAS REMOVED, AND THE TREATMENT WAS PERMANENTLY STOPPED DUE TO THE EVENT THE PATIENT HAD HYPERTHERMY AND ABDOMINAL PAIN.

  Patient problems: Abdominal Pain; Hyperthermia

  MAUDE report 7850508 ↗
• MalfunctionSep 8, 2017Detachment Of Device Component; Detachment Of Device Component

  THE CUSTOMER STATES DURING INSERTION OF THE CATHETER INTO THE PATIENT THE SECOND CUFF WAS DETACHED. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6851527 ↗