Argyle 8810888003Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Catheter,Tenckhoff, 2 Cuffs · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521004047), received between Sep 27, 2019 and May 9, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, WHEN THE HOSPITAL STAFF OPENED THE PACKAGE AND CHECKED THE PRODUCT BEFORE APPLIED ON THE PATIENT PRIOR TO USE, THE NURSES OBSERVED UNUSUAL AS THE TWO SITES OF CUFF (WHITE SPOTS ON THE TUBE) WERE NOT IN THE RIGHT POSITION. THERE WAS NO LEAK AND NO LUER ADAPTER ISSUE. THE CATHETER WAS NOT REPAIRED. THERE WERE NO OTHER DEFECTS/DAMAGES FOUND ON THE PRODUCT ASIDE FROM THE REPORTED ISSUE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. TEGO WAS NOT UTILIZED. NO CLEANING AGENT WAS USED AS THE REPORTED PRODUCT WAS ACCOUNTED TO DISPOSABLE CONSUMABLES. THERE WAS NO DAMAGE TO THE EXTERNAL PACKAGING OF THE PRODUCT. THERE WAS NO DAMAGE TO THE DEVICE¿S BOX. THE REPORTED PRODUCT WAS NOT REPLACED YET. THEY WOULD REPLACE ADDITIONAL BATCH OF THE SAME PRODUCTS AS THE REMEDIAL ACTION PERFORMED TO RESOLVE THE ISSUE. THE PHYSICIAN DID NOT START TO USE THE PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19282280 ↗MalfunctionSep 27, 2019Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD A CRACK IN THE TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9132265 ↗
Other CATHETER, PERITONEAL, LONG-TERM INDWELLING devices
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- Flex-Neck® 00884450305850Merit Medical Systems, Inc. · Catheter, peritoneal, long-term indwelling1 recall0 reports
- Flex-Neck® 00884450170069Merit Medical Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall0 reports
- Argyle 8888415604Mozarc Medical US LLC · Catheter, peritoneal, long-term indwelling48 reports
- Argyle 8888423103Mozarc Medical US LLC · Catheter, Peritoneal, Long-Term Indwelling42 reports
- Argyle 8888411405Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING33 reports
- Argyle 8888413807Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING16 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.