ArgyleRecalls & reported problems across all models
Mozarc Medical US LLC · 36 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 336
- Deaths reported
- 1
- Injuries reported
- 72
- Recalls
- 0
We found 36 models of Argyle by Mozarc Medical US LLC in the FDA's device registry (GUDID). Together they are named in 336 adverse event reports in the FDA's MAUDE database, received between Nov 10, 2000 and Feb 11, 2026 — classified as 1 death, 72 injuries, 262 malfunctions.
The most frequently reported specific device problem is “Break” (168 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Argyle problems
Device problems
- Break168
- Migration52
- Connection Problem40
- Detachment of Device or Device Component35
- Defective Component20
- Product Quality Problem12
- Leak/Splash10
- Insufficient Flow or Under Infusion9
Patient problems
- No Clinical Signs, Symptoms or Conditions174
- No Consequences Or Impact To Patient59
- Insufficient Information57
- Peritonitis19
- No Information15
- Foreign Body In Patient14
- Unintended Radiation Exposure13
- Unspecified Infection13
Argyle models
36 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Argyle 8811313010CATHETER, PERITONEAL, LONG-TERM INDWELLING1 death75 reports
- Argyle 8888415604Catheter, peritoneal, long-term indwelling48 reports
- Argyle 8888423103Catheter, Peritoneal, Long-Term Indwelling42 reports
- Argyle 8888411405CATHETER, PERITONEAL, LONG-TERM INDWELLING33 reports
- Argyle 8888413807CATHETER, PERITONEAL, LONG-TERM INDWELLING16 reports
- Argyle 8888412007CATHETER, PERITONEAL, LONG-TERM INDWELLING14 reports
- Argyle 8817278006CATHETER, PERITONEAL, LONG-TERM INDWELLING11 reports
- Argyle 8811313015CATHETER, PERITONEAL, LONG-TERM INDWELLING9 reports
- Argyle 8888411702CATHETER, PERITONEAL, LONG-TERM INDWELLING8 reports
- Argyle 8817278007CATHETER, PERITONEAL, LONG-TERM INDWELLING7 reports
- Argyle 8888425710CATHETER, PERITONEAL, LONG-TERM INDWELLING7 reports
- Argyle 8888412619CATHETER, PERITONEAL, LONG-TERM INDWELLING6 reports
- Argyle 8888413815CATHETER, PERITONEAL, LONG-TERM INDWELLING6 reports
- Argyle 8888413823CATHETER, PERITONEAL, LONG-TERM INDWELLING6 reports
- Argyle 8888412015CATHETER, PERITONEAL, LONG-TERM INDWELLING5 reports
- Argyle 8888423111CATHETER, PERITONEAL, LONG-TERM INDWELLING4 reports
- Argyle 8888411009CATHETER, PERITONEAL, LONG-TERM INDWELLING3 reports
- Argyle 8888413419CATHETER, PERITONEAL, LONG-TERM INDWELLING3 reports
- Argyle 8888413831CATHETER, PERITONEAL, LONG-TERM INDWELLING3 reports
- Argyle 8888414011CATHETER, PERITONEAL, LONG-TERM INDWELLING3 reports
- Argyle 8888422170CATHETER, PERITONEAL, LONG-TERM INDWELLING3 reports
- Argyle 8810807001CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8814661001Catheter,intravascular,therapeutic,short-term less than 30 days2 reports
- Argyle 8810888003CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8811313013CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8815677001CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8817278008CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8888410506CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8888413401CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8888111132CATHETER, PERITONEAL, LONG-TERM INDWELLING2 reports
- Argyle 8888411710CATHETER, PERITONEAL, LONG-TERM INDWELLING1 report
- Argyle 8888413102CATHETER, PERITONEAL, LONG-TERM INDWELLING1 report
- Argyle 8888411447Catheter, Peritoneal, Long-Term Indwelling1 report
- Argyle 8888425702Catheter, Peritoneal, Long-Term Indwelling1 report
- Argyle 8888423624Catheter, Peritoneal, Long-Term Indwelling1 report
- Argyle 8810805001CATHETER, PERITONEAL, LONG-TERM INDWELLING1 report
Recent Argyle adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 11, 2026Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, ON (B)(6) 2025, AT 6 PM, THE PATIENT FOUND THAT THE FABRIC COVERING THE CATHETER OUTLET WAS "WET," THE NURSE STATED THAT AFTER USE OF THE PRODUCT, THE CATHETER HAS BEEN DAMAGED AND LEAKED AT THE CATHETER SHAFT (JUNCTION OF THE BIFURCATE). THE REMEDIAL ACTION WAS THAT THE CATHETER WAS CLAMPED WITH A SMALL WHITE CLIP FIRST, AND PERITONEAL DIALYSIS WAS SUSPENDED AND WAS NOT COMPLETED. THE CATHETER WAS IN PLACE FOR ELEVEN YEARS AND FIVE MONTHS. ON (B)(6) 2025, THE PATIENT WENT TO THE EMERGENCY ROOM, WHERE THE NURSE FOUND A TEAR IN THE CATHETER DUE TO CATHETER DAMAGE. ON (B)(6) 2025, THE ANTIBIOTIC TREATMENT WAS CHANGED TO IV THERAPY. NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. TITANIUM METAL JOINT WAS THE OTHER PRODUCT BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THE PATIENT WAS TREATED UNDER GENERAL ANESTHESIA. THE WOUND DRESSING WAS APPLIED WITH THE CATHETER EXIT SITE BEING CLEANED WITH NORMAL SALINE AND GENTAMICIN CREAM. THE WOUND DRESSING DOES NOT INCLUDE ANY CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES. THE CLEANING AGENTS ARE ALLOWED TO DRY THOROUGHLY BEFORE THE DRESSING IS APPLIED TO THE AREA. THE CLEANIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24313884 ↗InjuryFeb 11, 2026Break; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, ON (B)(6) 2025, THE PATIENT WAS TREATED FOR PERITONITIS WITH ANTIBIOTICS (CEFTAZIDIME 1 G IP QD, VANCOMYCIN 1 G IP ON TUESDAYS AND FRIDAYS) DUE TO DAMAGED CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions; Peritonitis
MAUDE report 24313209 ↗InjuryNov 12, 2025Break; Break
ACCORDING TO THE REPORTER, DURING USE, THE PRODUCT WAS FOUND TO BE DAMAGED AND HAD A LEAK ON THE SHAFT. THERE WAS NOTHING UNUSUAL OBSERVED ON THE DEVICE PRIOR TO USE. FLUSHING WAS DONE PRIOR TO USE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE APPLIED ON THE DEVICE. THERE WERE NO IMPACTS AND NO ADVERSE EVENTS OR SYMPTOMS TO THE PATIENT. THE CLEANING AGENT USED ON THE CATHETER IN ITS ENTIRETY WAS NORMAL SALINE SOLUTION. GENTAMICIN WAS THE OINTMENT UTILIZED AT THE EXIT SITE. COVERING WITH REGULAR GAUZE WAS THE WOUND DRESSING UTILIZED. THERE WERE NO CLEANING AGENTS OR ANTIMICROBIAL PROPERTIES INCLUDED IN THE WOUND DRESSING. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE PATIENT WAS RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. THE CLEANING AGENTS WERE NOT SWITCHED OVER THE LIFE OF THE CATHETER. THE CLEANING AGENTS WERE NOT MIXED. SEPSIDERM WAS NOT USED TO CLEAN CATHETERS. THERE WAS NO PROTOCOL CHANGE USED FOR CLEANING AGENTS. THE PATIENT THEMSELVES USED AN ANTIBIOTIC (GENTAMICIN CREAM) ON THE CATHETER. ASIDE FROM THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE
Patient problems: Insufficient Information
MAUDE report 23536648 ↗MalfunctionOct 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, ON THE DAY OF THE EVENT, THE PERITONEAL DIALYSIS CATHETER PLACEMENT SURGERY WAS PERFORMED. THE EXTERNAL PACKAGING OF THE CATHETER AND ACCESSORIES WAS INTACT, BUT PREOPERATIVE EXAMINATION REVEALED SEPARATION/DETACHMENT OF THE CUFF FROM THE CATHETER ON THE PERITONEAL DIALYSIS CATHETER AND ACCESSORIES. IT WAS ALSO MENTIONED THAT SOMETHING UNUSUAL HAD BEEN OBSERVED ON THE DEVICE PRIOR TO USE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AN EXCESSIVE FORCE USE ON THE DEVICE. AS A REMEDIAL ACTION AND INTERVENTION, A NEW PERITONEAL DIALYSIS CATHETER WAS REPLACED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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 23278025 ↗MalfunctionAug 18, 2025Break; Break
ACCORDING TO THE REPORTER, PREOPERATIVELY, A HOLE WAS OBSERVED AT THE CUFF OF THE PERITONEAL DIALYSIS CATHETER. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834204 ↗MalfunctionAug 7, 2025Break; Break
ACCORDING TO THE REPORTER, DURING PERITONEAL DIALYSIS CATHETERIZATION SURGERY, AFTER THE PERITONEAL DIALYSIS CATHETER AND ACCESSORIES WERE OPENED, THE SURGEON CHECKED THE INTEGRITY OF THE CATHETER AND FOUND A 0.1 CM (CENTIMETER) CRACK IN THE MIDDLE OF THE CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 22745455 ↗MalfunctionAug 7, 2025Break; Break
ACCORDING TO THE REPORTER, THE OUTER PACKAGING OF THE PRODUCT WAS NOT DAMAGED. HOWEVER THE TUBE INSIDE WAS BROKEN. THE CATHETER WAS NOT REPAIRED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737392 ↗MalfunctionAug 6, 2025Break; Break
ACCORDING TO THE REPORTER, DURING DIALYSIS TREATMENT, IT WAS FOUND THAT THE CATHETER HAD A WATER LEAK AT THE EXIT SITE. THE CATHETER WAS NOT REPAIRED. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22733235 ↗MalfunctionJul 3, 2025Product Quality Problem; Detachment of Device or Device Component; Product Quality Problem; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE INTRODUCER NEEDLE THAT WAS IN THE KIT SNAPPED AT THE NEEDLE WHEN IT WAS BEING INTRODUCED INTO THE PATIENT'S ABDOMEN THROUGH A SURGICAL INCISION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22401370 ↗MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE NURSE REPORTED THAT DURING USE IT WAS DISCOVERED THAT THE PRODUCT HAS NO CUFF. THE PERITONEAL DIALYSIS (PD) CATHETER IN THE PATIENT SHOULD NORMALLY HAVE AN EXTERNAL CUFF AND AN INTERNAL CUFF. THE INTERNAL CUFF WAS MISSING IN THE PATIENT, WHICH CAUSED THE CATHETER TO PROLAPSE DURING SLEEP AT NIGHT. THERE WERE NO ADVERSE EVENTS OR SYMPTOMS/IMPACTS. THERE WAS NO LEAK. THERE WAS NO LUER ADAPTER ISSUE. NO CLEANING AGENT WAS USED ON THE DEVICE. TWO YEARS EARLIER, THE CATHETER HAD BEEN EXAMINED IN THE OPERATING ROOM, AND NOTHING WAS UNUSUAL. AS A REMEDIAL ACTION, AFTER THE PD TUBE WAS REMOVED, HEMODIALYSIS WAS TEMPORARILY SWITCHED. THE CUFF WAS NOT FOUND WHEN REPLACED WITH A NEW CATHETER IN THE OPERATING ROOM. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THE INTERVENTION/TREATMENT REQUIRED WAS TO CHANGE TO HEMODIALYSIS (HD) TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385177 ↗MalfunctionJun 18, 2025Break; Break
ACCORDING TO THE REPORTER, THE PATIENT UNDERWENT PERITONEAL DIALYSIS CATHETER PLACEMENT ON (B)(6) 2025. INTRAOPERATIVE AND POSTOPERATIVE EXAMINATIONS REVEALED NO LEAKS IN THE PERITONEAL DIALYSIS CATHETER. ON THE DAY OF THE EVENT, AT 9:00 AM, DURING THE DRESSING CHANGE OF THE ABDOMINAL SURGICAL SITE, A LEAK WAS OBSERVED AT THE TITANIUM CONNECTOR OF THE PERITONEAL DIALYSIS CATHETER APPROXIMATELY 0.5 CM FROM THE CONNECTION POINT. THIS LEAK POSED A RISK OF SEVERE INFECTIONS SUCH AS PERITONITIS AND COULD COMPROMISE DIALYSIS EFFICACY. IMMEDIATE MEASURES INCLUDED CLAMPING THE TUNNEL EXIT OF THE PERITONEAL CATHETER WITH A BLUE CLAMP, FOLLOWED BY ANTISEPTIC FLUSHING WITH POVIDONE-IODINE SOLUTION. THE TITANIUM CONNECTOR AND THE SHORT PERITONEAL DIALYSIS CATHETER WERE REPLACED. THE PATIENT WAS ADMINISTERED ORAL LEVOFLOXACIN FOR THREE DAYS FOR INFECTION PROPHYLAXIS. ROUTINE ANALYSIS AND CULTURE OF THE PERITONEAL DIALYSIS EFFLUENT WERE PERFORMED, WITH NO SIGNS OF FEVER, ABDOMINAL PAIN, OR OTHER DISCOMFORT OBSERVED. A CRACK WAS OBSERVED AT THE LUER ADAPTER. TEGO WAS NOT UTILIZED. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. AS A REMEDIAL ACTION, THE CATHETER WAS REPAIRED. THERE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22284216 ↗MalfunctionJun 2, 2025Break; Break
ACCORDING TO THE REPORTER, ON THE SECOND DAY OF PLACEMENT, DURING DIALYSIS AFTER CATHETERIZATION, FLUID LEAKED FROM THE EXTRACORPOREAL EXTENSION. THERE WAS A LEAK AT THE EXIT SITE, WHICH REFERRED TO THE EXTERNAL SEGMENT OF THE CATHETER EXTENDING FROM THE SKIN. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. FLUSHING WAS DONE PRIOR TO USE WITH NO ANOMALIES OBSERVED. NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE, AND NOTHING UNUSUAL WAS OBSERVED ON THE DEVICE PRIOR TO USE. NO OTHER DEFECTS OR DAMAGES WERE FOUND ON THE PRODUCT. NO LOTIONS OR MEDICATIONS WERE USED TO TREAT THE PATIENT. IODOPHOR WAS THE CLEANING AGENT USED ON THE DEVICE, AND IT WAS TYPICALLY UTILIZED TO CLEAN THE CATHETER IN ITS ENTIRETY. NO OINTMENTS WERE UTILIZED AT THE EXIT SITE. THE CLEANING AGENT WAS ALLOWED TO DRY THOROUGHLY PRIOR TO DRESSING THE AREA. THE PATIENT WAS NOT RESPONSIBLE FOR ANY TYPE OF CATHETER MAINTENANCE. CLEANING AGENT WAS NEVER SWITCHED OR MIXED OVER THE LIFE OF THE CATHETER, AND SEPSIDERM WAS NOT USED TO CLEAN CATHETERS ON THE SITE. THERE HAD BEEN NO RECENT PROTOCOL CHANGE FOR CLEANING AGENTS USED, AND THE PATIENT THEMSELVES WAS NOT USING ANY TYPE OF CLEANING AGENT OR ANTIBIOTIC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22127848 ↗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 ↗InjuryMay 19, 2025Break; Break
ACCORDING TO THE REPORTER, AFTER DIALYSIS, THE PD (PERITONEAL DIALYSIS) CATHETER HAD A CRACK/HOLE/TEAR IN THE TUBE, AND THERE WAS A LEAK LOCATED AT THE CATHETER SHAFT. THE CLEANING AGENTS USED ON THE DEVICE WERE VANCOMYCIN AND CEFTAZIDIME. A TEGO WAS NOT UTILIZED, AND THERE WAS NO LUER ADAPTER ISSUE. THE CLINICAL CONSEQUENCE REQUIRED REPAIRING THE DEFECTIVE CATHETER BY CLEANLY CUTTING IT OFF, REPLACING THE CONNECTION SCREW AND TRANSFER SYSTEM, AND PROVIDING PROPHYLACTIC CARE FOR PERITONITIS WITH VANCOMYCIN AND CEFTAZIDIME. THE BROKEN CATHETER TUBE WAS CONNECTED TOGETHER WITH A COMPETITOR'S LUER-LOCK CONNECTION. THE PERSONAL INJURY INVOLVED ABDOMINAL EMPTYING.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22044684 ↗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 ↗
Other Mozarc Medical US LLC products
All Mozarc Medical US LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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