ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5025-BCRecalls & reported problems
Silk Road Medical, Inc. · 5mm X 25mm · Class 2
Data updated Oct 18, 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 00811311020942), received between May 21, 2025 and May 21, 2025 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Vascular Dissection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A DISSECTION OCCURRED REQUIRING ADDITIONAL INTERVENTION. AN ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. THE PATIENT PRESENTED AS ASYMPTOMATIC. THE CLAMP WAS ON AND FLOW REVERSAL WAS ESTABLISHED. WHEN ATTEMPTING TO CROSS THE LESION WITH THE 0.014 GUIDEWIRE, THE ENFLATE BALLOON UNINTENTIONALLY LED THE WIRE, RESULTING IN A DISSECTION OF THE LEFT COMMON CAROTID ARTERY (CCA). THE TRUE LUMEN WAS ACCESSED AND AN ADDITIONAL ENROUTE STENT WAS USED TO COVER THE DISSECTION. THE TCAR PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER CLOSURE OF THE CAROTID ARTERY, ULTRASOUND WAS USED TO INTERROGATE THE ACCESS SITE FOR REMAINING DISSECTION. THIS WAS NEGATIVE FOR DISSECTION. THE PATIENT WAS EXPECTED TO FULLY RECOVER.
Patient problems: Vascular Dissection
MAUDE report 22060059 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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