RAILWAY RW7VBTHRecalls & reported problems
Cordis Corporation · RAILWAY ACCESS KIT, 7F, VBT, HW WIRE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705032076913), received between Jun 29, 2021 and Jun 29, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vasoconstriction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DURING ADVANCEMENT OF A 7F RAILWAY SHEATHLESS ACCESS SYSTEM, A SPASM OCCURRED AND HENCE, IT COULD NOT CROSS. THE SPASM WAS TREATED WITH NITROGLYCERIN (NTG). THE PROCEDURE WAS COMPLETED USING A FEMORAL APPROACH. THE PATIENT WAS NORMAL AFTER THE PROCEDURE. A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE WAS BEING PERFORMED. THE ACCESS SITE DID NOT HAVE THROMBUS, EXTREME TORTUOSITY OR CALCIFIED PLAQUE. THERE WAS NO EVIDENCE OF INADEQUATE CIRCULATION TO THE EXTREMITY AS EVIDENCED BY SIGNS OF ARTERY OCCLUSION OR ABSENCE OF RADIAL PULSE BEFORE INSERTION OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE COMPONENTS FROM THE PACKAGING AND NONE OF THE COMPONENTS APPEARED DAMAGE BEFORE USE. THE DILATOR WAS FLUSHED PRIOR TO USE. THE HYDROPHILIC COATING WAS HYDRATED WITH HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION PRIOR TO USE. ACCESS WITH THE .021¿ MINI GUIDEWIRE WAS ALREADY ACHIEVED WHEN THE SPASM OCCURRED. A NON-CORDIS GUIDE CATHETER WAS USED IN THE PROCEDURE. THE DEVICE WILL BE RETURNED FOR EVALUATION. PATIENT DEMOGRAPHICS INCLUDING THE REASON FOR THE PROCEDURE WERE NOT AVAILABLE.
Patient problems: Vasoconstriction
MAUDE report 12083878 ↗
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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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