SOFT-LINE® DUO-FLOW XTP114IJSERecalls & reported problems
Medical Components, Inc. · 11.5F X 12CM RAULERSON DUO-FLOW IJ DOUBLE LUMEN CATHETER SET (10 PER BOX) (KIT HAS 5 YR EXP DATE) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884908058857), received between Mar 2, 2018 and Nov 7, 2022 — classified as 5 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
Device problems
- Break5
Patient problems
- No Known Impact Or Consequence To Patient4
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2022Break; Break
HEMODIALYSIS WAS INITIATED FOR PATIENT. AFTER 10 MINUTES FOUND DRESSING SOAKED WITH BLOOD. BLOOD LEAKED OUT BETWEEN THE SPLIT CONNECTOR AND BLUE EXTENSION LINE. HEMODIALYSIS UNABLE TO PROCEED. NEW CATHETER WAS INSERTED WITH DIFFERENT BATCH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15742779 ↗MalfunctionMar 9, 2018Break; Break
PRIOR TO THE START OF DIALYSIS THE DRESSING WAS OPENED AND THE CATHETER SUTURE WING WAS FOUND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7327226 ↗MalfunctionMar 2, 2018Break; Break
PRIOR TO THE START OF DIALYSIS THE DRESSING WAS OPENED AND THE CATHETER SUTURE WING WAS FOUND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7309472 ↗MalfunctionMar 2, 2018Break; Break
PRIOR TO THE START OF DIALYSIS THE DRESSING WAS OPENED AND THE CATHETER SUTURE WING WAS FOUND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7309464 ↗MalfunctionMar 2, 2018Break; Break
PRIOR TO THE START OF DIALYSIS THE DRESSING WAS OPENED AND THE CATHETER SUTURE WING WAS FOUND BROKEN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7309461 ↗
Other CATHETER, HEMODIALYSIS, NON-IMPLANTED devices
- MAHURKAR 8888135191Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall175 reports
- MAHURKAR 8888135241Mozarc Medical US LLC · CATHETER, HEMODIALYSIS, NON-IMPLANTED1 recall1 death100 reports
- ARROW IPN036723Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls2 reports
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex Incorporated · Catheter, hemodialysis, non-implanted2 recalls0 reports
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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