RAILWAY RW6VBTBRecalls & reported problems
Cordis US Corp. · RAILWAY ACCESS KIT, 6F, VBT, SS WIRE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 10705032076906), received between Oct 18, 2021 and Feb 17, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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
- Device Contamination with Chemical or Other Material1
- Partial Blockage1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2022Partial Blockage; Device Contamination with Chemical or Other Material; Partial Blockage; Device Contamination with Chemical or Other Material
AS REPORTED, A 6F RAILWAY ACCESS KIT COULD NOT PASS AN UNKNOWN STANDARD 035 J WIRE THROUGH. ANOTHER RAILWAY ACCESS KIT WAS USED TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED TO THE PATIENT. DURING PRODUCT ANALYSIS A LENGTHWISE SECTION CUT WAS PERFORMED ON THE OBSTRUCTED AREA TO ANALYZE THE FUSION AREA OBSERVING THAT THE PROBLEM WAS CAUSED BY A FOREIGN MATERIAL. THE RESISTANCE WITH THE WIRE WAS MET IMMEDIATELY. THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE IFU. THE PRODUCT WAS INSPECTED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEVICE WOULD NOT FLUSH OUT BOTH ENDS FULLY. NOTHING UNUSUAL WAS NOTED ABOUT THE DEVICE PRIOR TO USE. NO OTHER DEVICES WERE USED WITH THE PRODUCT. THE DEVICE IS BEING RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13551548 ↗MalfunctionOct 18, 2021Separation Failure; Separation Failure
A PHYSICIAN REMOVED A SHEATHLESS CATHETER FROM A 6F RAILWAY SHEATHLESS ACCESS SYSTEM AND WAS WIPING THE RAILWAY DOWN WHEN IT SNAPPED COMPLETELY IN HALF. THE COMPONENT THAT SHEARED OFF WAS NOT RETAINED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12647137 ↗
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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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