Argyle 8888412007Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521004375), received between Jul 9, 2018 and Oct 9, 2023 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, THE PERITONEAL TUBE HAD WATER LEAKAGE. THE LEAK WAS OBSERVED AT THE EXTERNAL PART OF THE CATHETER. THERE WAS NO LUER ADAPTER ISSUE. ASIDE FROM THE LEAK, THERE WAS A HOLE THAT WAS OBSERVED ON THE PRODUCT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. LINK TITANIUM CONNECTOR WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. CLEANING AGENT WAS NOT USED ON THE DEVICE. CUTTING OFF THE LEAKING PART AT THE FRONT END TO MAKE THE TUBE SHORTER FOR USE, RECONNECT AND TREATED WITH ANTIBACTERIAL WAS THE REMEDIAL ACTION PERFORMED AND INTERVENTION/TREATMENT PROVIDED AS A RESULT OF THE LEAKAGE. THE PRODUCT WAS NOT REPLACED. THE PROCEDURE WAS PROCEEDED AND COMPLETED AFTER THE RESOLUTION/REMEDIAL ACTION WAS DONE. THERE WAS NO BLOOD LOSS AND NO BLOOD TRANSFUSION REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 17901565 ↗
• MalfunctionMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING SURGERY, IT WAS FOUND THAT THE INNER AND OUTER CUFFS OF THE PERITONEAL DIALYSIS TUBE WERE FOUND TO BE DETACHED AND SEPARATED FROM THE TUBE BODY. THE PERITONEAL DIALYSIS TUBE CUFF BECAME LOOSE. THERE WERE NO BROKEN PIECES OF THE DEVICE THAT FELL INSIDE THE PATIENT'S BODY. THE CATHETER WAS NOT REPAIRED AND THERE WAS NO LEAK. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED AND THERE WAS NO CONNECTOR ISSUE. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE, THERE WERE NO DAMAGES NOTED ON THE PRODUCT, THERE WERE NO OTHER PRODUCTS UTILIZED WITH THE DEVICE AND FLUSHING WAS DONE WITH NORMAL RESULT. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PRODUCT WAS REPLACED WITH A NEW PERITONEAL DIALYSIS CATHETER TO RESOLVE THE ISSUE AND PROCEDURE WAS COMPLETED. THERE WAS NO BLOOD LOSS AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO INTERVENTION/MEDICAL TREATMENT REQUIRED AS THE RESULT OF THE EVENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001988 ↗
• MalfunctionDec 20, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING INSERTION OF THE CHRONIC CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS) CATHETER UNDER LOCAL ANESTHESIA, WHEN FLUID WAS FLUSHED FOR TESTING TO THE PERITONEUM CAVITY, THE HCP (HEALTHCARE PROFESSIONAL) FOUND THAT THERE WAS A FLUID/DIALYSATE SOLUTION LEAK NEAR THE DEEP CUFF WHICH WAS TO BE PLACED DEEP IN THE ABDOMINAL WALL BEFORE ENTERING PERITONEAL CAVITY (CUFF NEAR THE INTERNAL PORTION OF THE CATHETER). THE LEAK WAS DISCOVERED DURING THE IMPLANTATION ITSELF, PROCEDURE WAS IN PROGRESS, IT WAS NEVER COMPLETED BEFORE THE LEAK WAS NOTICED, THE PATIENT DID NOT REQUIRE ANY DIAGNOSTIC TESTING TO CHECK THE LEAK, AND THERE WAS NO LEAK FROM THE EXIT SITE BEFORE DISCOVERING THE LEAK NEAR THE CUFF. ON THE CLOSER EXAMINATION, UPON THE REMOVAL, THE HCP FOUND A BREAKAGE (CRACK/CUT) AT THE TRANSPARENT TUBE NEAR THE DEEP CUFF OF THE CATHETER, IT WAS STILL INTACT, IMMEDIATELY A FRESH/NEW CHRONIC PD (PERITONEAL DIALYSIS) CATHETER WAS INSERTED/USED AS INTERVENTION ON THE SAME DAY OF EVENT AND THE PROCEDURE WAS COMPLETED. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE, AND BETADINE WAS THE CLEANING AGENT USED ON THE DEVICE. THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044687 ↗
• MalfunctionJan 3, 2020Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, ON CATHETER INSERTION FOR CAPD (CONTINUOUS AMBULATORY PERITONEAL DIALYSIS), WHILE CHECKING THE INFLOW OF THE DEVICE, THEY FOUND A LEAK FROM THE INNER CUFF SITE OF THE CATHETER. THE CATHETER WAS NOT REPAIRED, TEGO WAS NOT UTILIZED, THERE WAS NO LUER ADAPTER ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546430 ↗
• MalfunctionDec 7, 2018Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE REPORTER, AFTER TUBE PLACEMENT FOR HOME TREATMENT, THE PERITONEAL DIALYSIS CATHETER WAS FOUND THINNER THAN BEFORE. THE DOCTOR DESCRIBED THE TUBE'S WALL BECAME THIN AND CRISP, EASILY BROKEN OR BROKEN OR SUSPECTED TO BE FRACTURED, AND PART OF THEM WERE DIRECTLY DISCONNECTED. IT WAS STATED THAT THE PATIENT FOUND THE DEVICE HAD LEAKED AND THEN WENT TO THE HOSPITAL. THE DOCTOR ALSO FOUND THE LEAKAGE DURING THE CHECKING. IT WAS ALSO STATED THAT THE CATHETER WAS NOT REPLACED COMPLETELY AND THEY JUST CUT OFF A SECTION OF THE TUBE WHICH HAD PROBLEMS THEN, AFTER DISINFECTION THE CATHETER WAS CONNECTED AGAIN. THE LOCATION OF THE PROBLEM WAS NOT IN THE BODY, BUT IN VITRO. CUSTOMER REPORTED NO COMPLAINTS WERE RECEIVED FROM THE PATIENT DUE TO INJURY CAUSED BY THE PRODUCT AND FEEDBACK FROM THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144558 ↗
• MalfunctionJul 24, 2018Break; Disconnection; Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE.

  Patient problems: No Consequences Or Impact To Patient; No Information; Tissue Damage

  MAUDE report 7714773 ↗
• MalfunctionJul 24, 2018Break; Degraded; Disconnection; Defective Component; Detachment of Device or Device Component; Break; Defective Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7714732 ↗
• MalfunctionJul 24, 2018Break; Disconnection; Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7714713 ↗
• MalfunctionJul 24, 2018Break; Disconnection; Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7714663 ↗
• MalfunctionJul 24, 2018Break; Defective Component; Detachment of Device or Device Component; Defective Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE. THE CATHETER WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7713624 ↗
• MalfunctionJul 24, 2018Break; Degraded; Disconnection; Defective Component; Detachment of Device or Device Component; Break; Defective Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE. THE CATHETER WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7713609 ↗
• MalfunctionJul 24, 2018Break; Defective Component; Detachment of Device or Device Component; Defective Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE. THE CATHETER WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7713601 ↗
• MalfunctionJul 24, 2018Break; Defective Component; Detachment of Device or Device Component; Defective Component

  ACCORDING TO THE REPORTER, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT AN ABNORMALITY WAS FOUND ON THE BROKEN PIPE WALL AND THE WALL OF THE TUBE WAS THINNER THAN BEFORE. THE CATHETER WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient; No Information; No Known Impact Or Consequence To Patient

  MAUDE report 7713584 ↗
• MalfunctionJul 9, 2018Disconnection; Fluid/Blood Leak; Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE PERITONEAL DIALYSIS CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. IT WAS ALSO STATED THAT THE DEVICE HAD A LEAK AT THE TITANIUM CONNECTOR. IT WAS REPORTED THAT THERE WERE MANY CASES WHERE THE CATHETER WAS DISCONNECTED AT THE TITANIUM JOINT JUNCTION. THESE CASES WERE NOTED FROM DIFFERENT BATCHES AND DIFFERENT PATIENTS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7669485 ↗