RAILWAY RW6ADTBRecalls & reported problems
Cordis US Corp. · RAILWAY ACCESS KIT, 6F, ADT, HW WIRE · 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 10705032076883), received between Aug 4, 2021 and Aug 4, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2021Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn
DURING REMOVAL OF THE DILATOR OF RAILWAY ACCESS KIT WITH 6F ADROIT AND STAINLESS STEEL (SS) GUIDEWIRE (GW), IT WAS NOTICED THAT THE DISTAL 10CM OF THE DILATOR WERE ALMOST FULLY DETACHED AND ONLY CONNECTED VIA A THIN THREAD. EVERYTHING COULD BE PULLED OUTSIDE THE GUIDING CATHETER (GC), AND PROCEDURE COULD BE PROCEEDED AS PLANNED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS STORED IN THE CATH LAB FOR FOUR MONTHS. THE DEVICE IN NOT RESTERILIZED. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL. THE DEVICE WAS PREPPED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO DIFFICULTY ENCOUNTERED FLUSHING THE DEVICE. THE DILATOR OF THE RAILWAY KIT WAS USED FOR TRACKING ONLY IN THIS PROCEDURE. DILATOR WAS USED THROUGH AN UNKNOWN 6F GUIDING CATHETER (GC) THAT WAS INSERTED THROUGH AN UNKNOWN 6F SHEATH. THERE WAS NO RESISTANCE WITH THE GC. THERE WAS NO EXCESSIVE FORCE USED DURING THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED. PER VISUAL ANALYSIS, A SEPARATED CONDITION WAS NOTED APPROXIMATELY AT 19.2 CM FROM DISTAL TIP OF THE SYSTEM DILATOR. THE AFFILIATE CONFIRMED THAT THE DEVICE WAS RECEIVED IN PIECES. THE SEPARATION TOOK P
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12274875 ↗
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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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