Argyle 8811313015Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10884521004115), received between Jun 26, 2017 and Jan 20, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2025Break; Break

  ACCORDING TO THE REPORTER, WHEN PASSING THE CATHETER, IT WAS FRACTURED. IT WAS STATED THAT ANOTHER CATHETER WAS REQUESTED AT THE SURGICAL PHARMACY. THERE WAS NO LEAK. THE TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21191730 ↗
• InjuryJun 21, 2021Break; Break

  ACCORDING TO THE REPORTER, THERE WAS A PRESENCE OF ABNORMALLY DILUTED BLOOD, PRESENCE OF AIR BUBBLES AND ABNORMALLY HIGH PRESSURE AS SOON AS THE PATIENT CONNECTED TO THE DIALYSIS GENERATOR. EMERGENCY DISCONNECTION OF THE PATIENT, CHANGE OF THE DIALYSIS AND GENERATOR CIRCUIT AND RECONNECTING THE PATIENT TO THE NEW MACHINE WERE DONE BUT THE SITUATION RECURRED. DISCONNECTION OF THE PATIENT IN EMERGENCY WAS DONE AGAIN. RADIOGRAPHY WITH OPACIFICATION OF THE CENTRAL VENOUS CATHETER WAS MADE URGENTLY. DEMONSTRATION OF THE OPACIFICATION OF THE TWO WAYS WAS DONE WHILE THE PRODUCT WAS INJECTED ONLY IN ONE WAY AND THE RESULT WAS IN FAVOR OF A CRACKED CATHETER. IT WAS SAID THAT THERE WAS A LEAK AT THE CATHETER SHAFT. NOTHING UNUSUAL OBSERVED PRIOR TO CONNECTION OF THE PATIENT TO THE DIALYSIS GENERATOR. THE CATHETER WAS NOT REPAIRED. THE CLEANING AGENT WAS NOT ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA AND PRIOR TO APPLYING OINTMENT TO THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE (CLEANING, DRESSING CHANGES, ETC.). THE CLEANING AGENTS WERE NOT EVER SWITCHED OVER THE LIFE OF THE CATHETER. CLEANING AGENTS WERE NOT EVER MIXED. THE SITE DID NOT EVER USE S

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12030516 ↗
• MalfunctionJun 7, 2021Infusion or Flow Problem; Infusion or Flow Problem

  ACCORDING TO THE REPORTER, DURING PLACEMENT OF THE PERITONEAL DIALYSIS CATHETER AND INFUSION, AT THE TIME OF PLACING THE CATHETER AND TESTING ITS CORRECT OPERATION WITH THE PASSAGE OF 500 ML OF SALINE SOLUTION, IT WAS EVIDENCED THAT THE SOLUTION DID NOT PASS THROUGH THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT'S CAVITY TO CHECK FOR ANY TYPE OF BLOCKAGE, CHECKING THAT THERE WERE NO TISSUE RESIDUES. WHEN TESTING IT OUT OF CAVITY IT WAS OBSERVED THAT THE SOLUTION DID NOT PASS PROPERLY. DEVICE WAS CHANGED FOR A NEW ONE AND DID NOT PRESENT ANY PROBLEM. THE CATHETER WAS NOT REPAIRED, THERE WAS NO LEAK, NO TEGO UTILIZED AND NO LUER ADAPTER ISSUE. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945867 ↗
• MalfunctionJun 29, 2020Break; Break

  ACCORDING TO THE REPORTER, IT WAS SAID THAT HOLE AND LEAKAGE WERE FOUND (UPON REMOVAL OF THE DEVICE) ON THE CATHETER SHAFT WHICH WAS BETWEEN THE TWO CUFFS OF THE PERITONEAL CATHETER THAT WAS INSERTED INTO THE PATIENT. IT WAS MENTIONED THAT THE ISSUE WAS DISCOVERED BEFORE TUNNELING WAS PERFORMED. NO OOZING OF LIQUID WAS COMING FROM THE INCISION SITE AND THERE WAS NO MIGRATION OR MOVEMENT. THERE WAS NOTHING UNUSUAL OBSERVED WITH THE DEVICE PRIOR TO THE PROCEDURE AND THERE WAS NO DAMAGE FOUND ON THE PACKAGE OR KIT EITHER. FLUSHING WAS DONE PRIOR TO INSERTION AND SOME RESISTANCE WAS NOTED. IT WAS STATED THAT THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE AND THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THE REPORTED DEVICE WAS REMOVED AND WAS REPLACED. THE PROCEDURE WAS NOT COMPLETED BUT IT WAS RESCHEDULED. IT WAS MENTIONED THAT FOR THE NEW CATHETER INSERTION, THERE WAS NO CLEANING AGENT USED. THE SECOND PROCEDURE WAS SUCCESSFUL WITH NO KNOWN COMPLICATIONS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10205478 ↗
• MalfunctionNov 5, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING USE, THE PATIENT NOTICED THAT THE DRESSING OF HIS PERITONEAL DIALYSIS CATHETER WAS WET. HE IMMEDIATELY DROVE TO THE HOSPITAL WHERE A HOLE IN THE CATHETER TUBE WAS DIAGNOSED SHORTLY AFTER THE EXIT SITE. PROPHYLACTIC ANTIBIOTICS WERE GIVEN TO PREVENT PERITONITIS. LAPAROTOMIC PROCEDURE WAS DONE TO REPLACE THE PERITONEAL CATHETER. IT WAS STATED THAT CATHETER WAS FIXED WITH FIXOMULL AND THE PATIENT WAS NOT RESPONSIBLE FOR THE CATHETER MAINTENANCE AS HIS PRACTICE CLEANS THE EXIT SITE THREE TIMES A WEEK WITH AQUEOUS WOUND AND MUCOUS MEMBRANE ANTISEPTIC AND WAS FIXED WITH A GUT BELT. A CUSTOMER REPORTED THERE WAS NO WOUND WHEN THE PATIENT ARRIVED AT THE HOSPITAL WITH THE LEAKED CATHETER. THERE WAS ONLY AN EXIT SITE, WHICH WAS COVERED WITH STERILE COMPRESSES WHEN NOT USED. THESE COMPRESSES HAVE BEEN ALWAYS DRY AND NO OINTMENT WAS USED. THE PATIENT RECOVERED AFTER SURGICAL INTERVENTION AND WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039134 ↗
• InjuryJul 25, 2018Leak/Splash; Material Puncture/Hole; Deformation Due to Compressive Stress; Material Twisted/Bent; Unintended Movement; Deformation Due to Compressive Stress

  ACCORDING TO THE REPORTER, DURING USE, THE CATHETER HAD A LEAK AT THE EXIT SITE. THE PATIENT NOTICED THAT THE DRESSING OF HER PERITONEAL DIALYSIS CATHETER IMPLANTED WAS WET. THE PATIENT IMMEDIATELY DROVE TO THE CLINIC WHERE A HOLE IN THE CATHETER TUBE WAS DETERMINED SHORTLY AT THE EXIT. DUE TO ITS LOCATION, IT WAS NOT TECHNICALLY POSSIBLE TO CHANGE THE EXTENSION PIECE. ON THE SAME DAY, A LAPAROTOMIC ONE-SIDED PERITONEAL DIALYSIS CATHETER CHANGE TOOK PLACE. IT WAS STATED THAT THE PATIENT FIRST NOTICED THE CATHETER SPONTANEOUSLY TWISTED ITSELF AT THE EXIT AND A SMALL GROOVE ON THE CATHETER WAS NOTICED AS WELL. IT WAS ALSO INDICATED THAT THE CATHETER SPONTANEOUSLY TWISTED ITSELF ONCE A WEEK. THE PATIENT HAS BEEN PERFORMING THE DAILY CONTINUOUS AMBULATORY PERITONEAL DIALYSIS(CAPD) TREATMENTS WITH 3 X 1500 ML 1,36 % GLUCOSE (PHYSIONEAL 40) AND 1 X 2000 ML EXTRANEAL. THE PATIENT HAS BEEN RINSING THE EXIT IN THE SHOWER FOR 5 YEARS AND THEN DABBING IT DRY. THE PATIENT HAS ALSO CLEANED THE EXIT 4 TO 5 TIMES A WEEK WITH OCTENISEPT, AQUEOUS WOUND AND MUCOUS MEMBRANE ANTISEPTIC. THE PATIENT WAS REPORTED TO HAVE A COMPLICATION OF PERITONITIS AND SYMPTOM OF STOMACH PAIN.

  Patient problems: Peritonitis

  MAUDE report 7718445 ↗
• MalfunctionFeb 14, 2018Kinked; Kinked

  ACCORDING TO THE REPORTER, THE CATHETER SHAFT WAS KINKING AND ROLLING. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7270192 ↗
• MalfunctionSep 19, 2017Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  THE CUSTOMER STATES DURING USE THEY NOTICED THE CATHETER WAS LEAKING AND UPON FURTHER EXAMINATION FOUND A CRACK OF THE CATHETER ABOUT ONE INCH FROM THE EXIT SITE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6875215 ↗
• MalfunctionJun 26, 2017Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT AFTER INSTALLING THE CATHETER IS WAS FOUND TO BE OCCLUDED. THERE WAS NO PATIENT ADVERSE EVENT.

  Patient problems: No Information

  MAUDE report 6666959 ↗