Argyle 8888413401Recalls & reported problems
Mozarc Medical US LLC · Peritoneal Dialysis Catheter,Swan Neck Missouri Curl Cath, 2 Cuff Left,62.5 cm · 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 10884521004597), received between Aug 1, 2017 and Apr 15, 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
- Appropriate Device Problem Term/Code Not Available1
- Break1
Patient problems
- Insufficient Information1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 15, 2024Break; Break
ACCORDING TO THE REPORTER, DURING USE, THERE WAS A SMALL HOLE OR TEAR IN THE CATHETER JUST BELOW THE EXIT SITE. THE ADHESIVE PATCH WAS FOUND MOIST DURING THE CARE OF THE CATHETER. A MEDICAL INTERVENTION WAS REQUIRED TO REMOVE THE CATHETER, AS IT WAS IMPOSSIBLE TO SHORTEN SINCE IT WAS TOO CLOSE TO THE INSERTION POINT. A NEW CATHETER WAS IMPLANTED. THE PATIENT WAS SWITCHED TO HEMODIALYSIS FOR TWO WEEKS BEFORE USING THE NEW CATHETER. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: Insufficient Information
MAUDE report 19106014 ↗MalfunctionAug 1, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER STATES THE CATHETER WAS FOUND TO BE DISCONNECTED INSIDE THE PATIENT DURING A CT SCAN. THE CATHETER WAS REPLACED AND THERE WAS NO CONSEQUENCE TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6756679 ↗
Other CATHETER, PERITONEAL, LONG-TERM INDWELLING devices
- Argyle 8811313010Mozarc Medical US LLC · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 death75 reports
- Aspira Drainage Kit 4992301Bard Access Systems, Inc. · CATHETER, PERITONEAL, LONG-TERM INDWELLING1 recall4 reports
- 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.