Brevia Dialysis Catheter Kit 5563240Recalls & reported problems
Bard Access Systems, Inc. · Brevia Catheter Kit, 24 · Class 2 · Implant
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 00801741045448), received between Jul 5, 2018 and Jul 5, 2018 — 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
- Fracture1
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.
MalfunctionJul 5, 2018Fluid/Blood Leak; Fracture
THE FACILITY REPORTED THAT THE BREVIA CATHETER WAS FRACTURED NEAR THE BIFURCATION AND BEGAN LEAKING. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7664862 ↗
Other CATHETER, SUBCLAVIAN devices
- Permcath 8817748001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN2 deaths34 reports
- ARROW IPN030063Teleflex Incorporated · CATHETER, SUBCLAVIAN30 reports
- Hemo-Cath® SL18PMedical Components, Inc. · CATHETER, SUBCLAVIAN1 death25 reports
- Soft-Cell PC-2 Dialysis Catheter Kit 12.5 F x 19 cm 5534190Bard Access Systems, Inc. · CATHETER, SUBCLAVIAN17 reports
- Schon 10800702Angiodynamics, Inc. · CATHETER, SUBCLAVIAN8 reports
- ARROW IPN919725Teleflex Incorporated · Catheter, subclavian7 reports
- Permcath 8817749001Mozarc Medical US LLC · CATHETER, SUBCLAVIAN7 reports
- ARROW IPN919724Teleflex Incorporated · Catheter, subclavian6 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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