ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5035-BCRecalls & reported problems
Silk Road Medical, Inc. · 5mm X 35mm · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811311021017), received between Jul 3, 2024 and Dec 2, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Hematoma1
- Perforation of Vessels1
- Vascular Dissection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEMATOMA AND VESSEL DAMAGE, LEADING TO OPEN SURGERY AND ADDITIONAL COVERED STENT PLACEMENT. AN ENROUTE INFLATE TRANSCAROTID RX BALLOON WAS SELECTED FOR USE IN A LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. AN ENROUTE STENT WAS IMPLANTED AND POST DILATED USING THE INFLATE BALLOON. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE, AND FINAL IMAGES REVEALED NOTHING NOTABLE. THE PATIENT WAS MOVED TO THE POST ANESTHESIA CARE UNIT (PACU), AND SHORTLY THEREAFTER DEVELOPED A HEMATOMA. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM AND A REDO TCAR WAS PERFORMED, AT WHICH POINT VESSEL DAMAGE WAS NOTED. AN ADDITIONAL COVERED STENT WAS PLACED TO TREAT THE VESSEL DAMAGE. THE PHYSICIAN SUSPECTED THAT THE VESSEL DAMAGE MAY HAVE OCCURRED DURING POST-DILATION OF THE STENT. THE PATIENT REMAINED HOSPITALIZED AT THE TIME OF REPORTING.
Patient problems: Hematoma; Perforation of Vessels
MAUDE report 23698393 ↗InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PHYSICIAN INDICATED THAT A DISSECTION OCCURRED WITH EITHER THE ENROUTE TRANSCAROTID NEUROPROTECTION SYSTEM OR DURING ADVANCEMENT OF THE ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER. THE DISSECTION WAS TREATED BY PLACING A CONDUIT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Vascular Dissection
MAUDE report 19668755 ↗
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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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