Niagara Slim-Cath catheter 5551240Recalls & reported problems
Bard Access Systems, Inc. · 12Fr Niagara ST 24cm CathOnly · Class 2 · Implant
All models of Niagara Slim-Cath catheter (4)
Data updated Oct 18, 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 00801741041839), received between Oct 16, 2019 and Oct 16, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact 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 16, 2019Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING CRRT INITIATION MICRO AIR BUBBLES WERE NOTED IN THE AERATION CHAMBER IMMEDIATELY FOLLOWING START OF CRRT AS WELL AS AIR BUBBLES NOTED FROM THE ACCESS CATHETER THROUGHOUT CIRCUIT. THEY CHANGED THE FILTER THREE TIMES AND THE CRRT MACHINE ONCE TO RULE OUT FILTER OR MACHINE PROBLEM. THE AIR BUBBLE ISSUE ALLEGEDLY CONTINUED SO THEY WERE QUESTIONING A LINE CRACK. THE LINE WAS REMOVED AND A NEW ONE PLACED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9199595 ↗
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
- ARROW IPN036412Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- DuoGlide catheter 5625240Bard Access Systems, Inc. · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls1 report
- ARROW IPN036428Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN036419Teleflex Incorporated · CATHETER, HEMODIALYSIS, NON-IMPLANTED2 recalls0 reports
- ARROW IPN927343Teleflex 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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