Argyle 8888413807Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10884521004610), received between Jun 1, 2017 and May 23, 2025 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SURGERY, THE CUFF CAME OUT, FORCING THEM TO REPLACE THE CATHETER WITH THE SAME PRODUCT ID (IDENTIFIER), SINCE IT COULD NOT BE PLACED WITHOUT THE CUFF. THE CATHETER WAS NOT REPAIRED, AND THERE WAS NO LEAK. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077334 ↗
• MalfunctionOct 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, A DEFECTIVE CATHETER WAS DETECTED AT THE TIME OF SURGERY. WHEN ATTEMPTING TO PERFORM THE IMPLANT, THE CUFFS CAME OUT, REQUIRING THE REPLACEMENT OF THIS CATHETER DURING SURGERY SINCE IT CANNOT BE PLACED WITHOUT THE CUFFS. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. THE PRODUCT WAS RINSED PRIOR TO USE WITH A NORMAL RESULT. NO OTHER PRODUCTS ARE BEING USED WITH THE DEVICE. NO CLEANING AGENT WAS USED ON THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. AS A CORRECTIVE ACTION, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW CATHETER. THE PROCEDURE WAS COMPLETED. NO MEDICAL OR SURGICAL INTERVENTION IS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DIDN'T LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350336 ↗
• MalfunctionJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, WHILE PASSING THE CATHETER THROUGH TISSUE, BOTH CUFFS FELL OFF THE CATHETER. THE DEVICE WAS NOT REPAIRED AND THERE WAS NO LEAK. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18506499 ↗
• InjuryJan 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHEN USED IN SURGERY, THE CATHETER WAS BEING ADVANCED THROUGH TISSUE; HOWEVER, BOTH CUFFS ATTACHED TO THE DEVICE SPLIT OFF THE DEVICE. THE CUFFS FELL INSIDE THE PATIENT'S BODY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE, AND THE RESULT WAS NORMAL. NO OTHER PRODUCTS WERE BEING UTILIZED WITH THE DEVICE. NO CLEANING AGENT WAS USED ON THE DEVICE. PLACEMENT WAS PER STANDARD OPERATING PROCEDURE; THERE WAS NO TREATMENT FOR TISSUE. THE INITIAL PRIMARY PLACEMENT WAS IN A SURGICAL ENVIRONMENT. CHLORAPREP WAS THE AGENT OR SOLUTION USED ON THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. BOTH CUFFS WERE RETRIEVED BY LAPAROSCOPIC GRASPERSY ON THE SAME PROCEDURE. AN X-RAY MACHINE OR OTHER PROCEDURE WAS USED OR PERFORMED TO CHECK FOR RETAINED PIECES, AND ALL PIECES WERE IMMEDIATELY RETRIEVED INSIDE THE BODY. CUFFS AND THE PRODUCT WERE REMOVED FROM THE FIELD, AND A NEW PRODUCT OF THE SAME PRODUCT ID (IDENTIFIER) AND SAME LOT WAS OPENED AND USED ON THE SAME DAY UNDER THE SAME PROCEDURE AS REMEDIAL ACTION TO RESOLVE THE ISSUE, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS. A BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WER

  Patient problems: Unintended Radiation Exposure

  MAUDE report 18504347 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DOCTOR WHO WAS IN CONTACT WITH THE PATIENT'S CATHETER ALSO HAD AN ALLERGIC REACTION WITH FACIAL EDEMA. IT WAS MENTIONED THAT THE FACIAL EDEMA OCCURRED AS A DIRECT RESULT OF THE CATHETER AND HAD NO PREVIOUS ALLERGIC REACTION.

  Patient problems: Angioedema

  MAUDE report 17472307 ↗
• MalfunctionJul 26, 2023Break; Break

  ACCORDING TO THE REPORTER, THE CATHETER HAS BEEN IMPLANTED INTO THE PATIENT FOR 46 DAYS. THE PATIENT ATTENDED FOLLOW-UP APPOINTMENT TO EVALUATE PERITONEAL DIALYSIS TREATMENT AND PRESENTED WET CLOTHING WHEN REVISING THE CATHETER, A RUPTURE OF THE CATHETER WAS EVIDENT NEARLY AT THE EXIT SITE/ORIFICE AND FLUID LEAK WAS OBSERVED MAKING IT IMPOSSIBLE TO RESOLVE. THE CATHETER DELIVERY KIT CLAMP WAS PLACED AND PERFORMED AN HD (HEMODIALYSIS) SESSION WHERE VANCOMYCIN ANTIBIOTIC WAS GIVEN AS PROPHYLAXIS USED FOR CATHETER RUPTURE TOPREVENT FUTURE INFECTIONS. IN AT 120/80 HD, PRE-DIALYSIS WEIGHT WAS 81.3 KG (KILOGRAM) DRY WEIGHT WAS 80 KG, NON-REACTIVE PRE-DIALYSIS GLYCEMIC AND THERE WERE NO COMPLICATIONS DURING THE TREATMENT IT WAS STABLE, TA/BP (ARTERIAL/BLOOD PRESSURE) WAS 120/70, POST-DIALYSIS WEIGHT WAS 80.2 KG, POST-DIALYSIS GLYCAEMIA WAS NOT REPORTED DUE TO LACK OF REAGENTS. THE PATIENT REPORTED THAT THEY FELL AT HOME AND THIS WAS THE ONLY TRAUMATIC EPISODE THAT WARRANTS CATHETER RUPTURE (THE PATIENT ALLEGEDLY FELL AND BUMPED THE CATHETER). THE CATHETER ONLY CRACKED ONCE AFTER THE FALL SUFFERED BY THE PATIENT AND LEAK WAS OBSERVED IN THE AREA OF CRACK. IT WAS STATED THAT THE FRACTURE OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17401524 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE HAD BEEN COMPLICATIONS WITH A CATHETER IN THE PATIENT. THE CATHETER WAS PLACED INTO THE PATIENT AND HOURS LATER FACIAL EDEMA AND RESPIRATORY DISTRESS WERE PRESENTED, REQUIRING HOSPITALIZATION, SUPPORT AND CONTROL WERE CARRIED OUT AFTER PLACEMENT. AS A DIFFERENTIAL DIAGNOSIS, SUBCUTANEOUS EMPHYSEMA AND ALLERGIC REACTION TO THE CATHETER WERE CONSIDERED. THE PATIENT WAS ADMITTED TO THE CLINIC AT 1123. UPON ADMISSION, THE PATIENT PRESENTED FACIAL EDEMA IN WHICH AS REPORTED BEGAN YESTERDAY (ON (B)(6) 2023) AND HAD GRADUALLY INCREASED WHICH HAS NOT BEEN ESTABLISHED WITH THE PLACEMENT OF CORTICOSTEROIDS, THE AIRWAY IMPRESSES WELL IN THE SAME WAY IT WAS REFERRED FOR EVALUATION AND POSSIBLE HOSPITALIZATION. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED AND NOT REPLACED. IODINE-TOPICAL SOLUTION WAS THE CLEANING AGENT USED ON THE DEVICE AND USED TO CLEAN THE INSERTION SITE PRIOR TO PRODUCT PLACEMENT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE AND FLUSHING WAS DONE PRIOR TO USE WITH NORMAL RESULT. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. PROCEDURE WAS COMPLETED. THE PATIENT WAS

  Patient problems: Angioedema; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypersensitivity/Allergic reaction; Respiratory Insufficiency

  MAUDE report 17395926 ↗
• MalfunctionJul 18, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, AFTER THE PATIENT SUFFERED A FALL, HIT THE CATHETER PLACEMENT AREA. THE PATIENT'S DOCTOR WAS INFORMED VIA PHONE AND WHEN PERITONEAL DIALYSIS (PD) TREATMENT BEGAN IT WAS FOUND THAT THE CATHETER HAD A BREAK AT THE LEVEL OF THE RADIO-OPAQUE LINE AT THE TUNNEL, TWO CENTIMETERS OUTSIDE THE BODY. THE CATHETER DID NOT BREAK OFF COMPLETELY INSIDE THE PATIENT'S BODY. THE CATHETER WAS NOT REPAIRED. THERE WAS A LEAK AT THE CATHETER SHAFT. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE AND THE CATHETER COULD NOT BE USED DUE TO THE CUT. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS OR DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. CLEANING AGENTS WERE NOT ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT TO THE AREA. NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE AND EXCESSIVE FORCE WAS NOT USED ON THE DEVICE. THE PATIENT WENT ON HEMODIALYSIS AS A REMEDIAL ACTION TO RESOLVE THE ISSUE. THE CATHETER WAS REPLACED AS AN INTERVENTION OR TREATMENT REQUIRED AS A RESULT OF THE E VENT. THE TREATMENT WAS NOT COMPLETED AND THERE WAS NO BLOOD LOSS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17344670 ↗
• MalfunctionJun 19, 2023Break; Material Puncture/Hole; Break; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING THE INFUSION TO WASH THE CAVITY ON THE DAY OF THE EVENT, A FLUID LOSS WAS CONFIRMED THROUGH A SMALL PERFORATION CLOSE TO THE ADAPTER OR NEAR THE CONNECTOR WITH THE TRANSFER LINE. THE PERITONEAL CATHETER WAS PLACED IN PATIENT ON (B)(6) 2023 TO START CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE CATHETER HAD BEEN IN PLACE FOR 3 MONTHS. THE CATHETER WAS REPAIRED. THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT WHERE THE LEAK WAS OBSERVED. TEGO WAS NOT UTILIZED AND THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. A PHYSIOLOGICAL SOLUTION WAS INFUSED IN THE DEVICE AS A CLEANING AGENT. 10% IODINE AND GENTAMICIN OINTMENT (POMADE) WERE USED AT THE ORIFICE (EXIT SITE). THE CLEANING AGENTS WERE ALLOWED TO BE DRIED THOROUGHLY PRIOR TO DRESSING THE AREA. ONLY A GAUZE (CHIFFON) WAS USED AS A WOUND DRESSING AND IT DID NOT HAVE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. AFTER THE SURGERY, THE FIRST HEALING WAS DONE WITHIN 7 DAYS WITH 10% IODINE, AND ONLY IN THE SECOND HEALING INVOLVED THE PLACEMENT OF GE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17151800 ↗
• MalfunctionAug 4, 2021Break; Break

  ACCORDING TO THE REPORTER, IT WAS SAID THAT THE PATIENT NOTIFIED THE NURSE ON CALL THAT SHE THOUGHT THE PERMANENT PART OF HER PD (PERITONEAL DIALYSIS) CATHETER WAS LEAKING (PATIENT WAS NOT ON TREATMENT WHEN THE EVENT HAPPENED). THE PATIENT WAS DIRECTED TO GO TO THE ED (EMERGENCY DEPARTMENT) AT THE HOSPITAL TO HAVE THE PD CATHETER REPAIRED. THE WRITER MET HER THERE AND OBSERVED A PINPOINT AREA IN THE PERMANENT PART OF HER PD CATHETER THAT EXITS HER BODY. THE LEAK WAS SEEN AT THE END OF WHERE THE BETA CAP ADAPTER ENDED INSIDE THE CATHETER BUT THERE WAS NO DAMAGE AND NO CRACK NOTED ON THE BETA CAP ADAPTER, ONLY IN THE TUBING. IT WAS SAID THAT THE PATIENT WAS UNABLE TO COMPLETE USUAL PD PRESCRIPTION. THE EXIT SITE WAS CLEANSED WITH ANTIBACTERIAL SOAP WHILE THE CATHETER AT THE CONNECTION WOULD BE CLEANSED WITH BETADINE SOLUTION 6 MONTHS WHEN TRANSFER SET WAS BEING CHANGED. MUPIROCIN OINTMENT WAS THE OINTMENT BEING UTILIZED AT THE EXIT SITE. 2X2 GAUZE AND MEPORE WOUND DRESSING WERE UTILIZED. THE WOUND DRESSING DID NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS WERE ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA AND PRIOR TO APPLYING OINTMENT TO THE

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

  MAUDE report 12273919 ↗
• MalfunctionNov 3, 2020Break; Break

  ACCORDING TO THE REPORTER, ON (B)(6) 2020, THE PATIENT ARRIVED AT THE HOSPITAL AS THE CATHETER WAS CUT INTO TWO PIECES. THE DOCTOR ASKED IF IT WAS CUT MISTAKENLY AS IT DID NOT MAKE SENSE. THE CATHETER HAD BEEN CUT AND REPAIRED AND WAS FUNCTIONING WELL. FLUSHING WAS DONE ON THE DEVICE. ANTIBIOTICS WERE ALSO GIVEN. ON (B)(6) THIS YEAR, PATIENT CAME TO THE HOSPITAL WITH SMALL TEAR ON THE CATHETER. IT WAS STATED THAT A LEAK WAS NOTED ABOUT 15 CENTIMETERS AWAY FROM EXIT SITE CLOSE TO THE CONNECTOR. SEPTAL SCRUB 0.9% NACL / TAP WATER IN THE SHOWER WERE USED AS CLEANING AGENTS ON THE DEVICE. SEPTAL SCRUB FOLLOWED BY ELCOKSIDINE WAS THE CLEANING AGENTS USED ON THE INSERTION SITE PRIOR TO USE. CATHETER WAS REPAIRED AND IT WAS NOT REPLACED. ANTIBIOTICS WERE ALSO GIVEN. IT WAS STATED THAT THEY USED A TITANIUM CONNECTOR AND EXTENSION AND IT MIGHT BE THE PROBLEM. REGULAR WOUND DRESSING WAS UTILIZED AND NO ANTIMICROBIAL PROPERTIES. PATIENT WAS THE ONE RESPONSIBLE FOR THE CATHETER MAINTENANCE AND NOT USING ANY TYPE OF CLEANING AGENT. CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY PRIOR TO APPLYING OINTMENT AND DRESSING THE AREA. IT WAS STATED THAT THE CLEANING AGENT DID NOT EVER SWITCHED OVER THE

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10777838 ↗
• MalfunctionJul 1, 2020Break; Break

  ACCORDING TO THE REPORTER, DURING USE, IT WAS STATED THAT THERE WAS A CRACK AND LEAK OBSERVED IN THE PD (PERITONEAL DIALYSIS) CATHETER JUST NEXT TO THE SKIN EXIT SITE. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT USED ON THE DEVICE WERE POVIDONE IODINE AND MUPIROCIN OINTMENT. TEGO WAS NOT UTILIZED AND THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ONE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217135 ↗
• InjuryApr 18, 2018Break; Break

  ACCORDING TO THE REPORTER, IT WAS OBSERVED ON THE COMPUTED TOMOGRAPHY (CT) THAT THE CATHETER HAD BROKEN INTO TWO INSIDE THE PATIENT. THE PERITONEAL DIALYSIS (PD) CATHETER WAS REMOVED. A SURGICAL PROCEDURE WAS DONE FOR THE RETRIEVAL OF THE CATHETER AND A NEW ONE WAS IMPLANTED. THE CATHETER WAS PLACED 2 YEARS PRIOR. THE PATIENT HAS RECOVERED.

  Patient problems: Injury

  MAUDE report 7440755 ↗
• InjurySep 5, 2017Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATES THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2017 AND WAS SENT FOR A SCAN ON (B)(6) BECAUSE OF UNRESOLVED ABDOMINAL PAIN. THE SCAN INDICATED AIR IN THE ABDOMEN. NO LEAKING WAS NOTED AND THE PATIENT HAD NO COMPLAINT OF WETNESS OVER HER CLOTHES OR BED DURING DIALYSIS. PATIENT WENT FOR CATHETER REMOVAL DUE TO UNRESOLVED PERITONITIS ON (B)(6). THE SURGEON REMOVED THE CATHETER FROM THE PATIENT AND UPON TESTING OF THE CATHETER LEAKAGE WAS NOTED 2.7 CM AWAY FROM THE TITANIUM END.

  Patient problems: Peritonitis

  MAUDE report 6841599 ↗
• MalfunctionJun 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER DISCONNECTED FROM THE TRANSFER SET AT THE BETA CAP ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604096 ↗
• MalfunctionJun 1, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER.T HE CUSTOMER STATES THE CATHETERS DISCONNECTED FROM THE TRANSFER SET AT THE BETA CAP ADAPTER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604075 ↗