SOFT-LINE® DUO-FLOW XTP118IJSERecalls & reported problems
Medical Components, Inc. · 11.5F X 20CM 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908059786), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 22, 2020Leak/Splash; Leak/Splash
CATHETER WAS NOTED TO BE LEAKING A FEW DROPS OF BLOOD AT THE CONNECTION OF THE ARTERIAL EXTENSION, AND THE HUB. CATHETER WAS EXCHANGED IMMEDIATELY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10721759 ↗
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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