ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter SR-5535-BCRecalls & reported problems
Silk Road Medical, Inc. · 5.5mmx35mm · 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 00811311021024), received between Aug 6, 2025 and Jan 23, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
- Failure to Deflate1
- Material Integrity Problem1
Patient problems
- Vascular Dissection2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 23, 2026Failure to Advance
IT WAS REPORTED THAT A DISSECTION OCCURRED, REQUIRING AN ADDITIONAL STENT PLACEMENT. AN ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. WHEN ATTEMPTING TO CROSS THE LESION WITH THE 0.014 GUIDEWIRE, THE ENFLATE BALLOON EXITED THE SHEATH WITHOUT THE WIRE, RESULTING IN A DISSECTION OF THE COMMON CAROTID ARTERY (CCA). THE SHEATH WAS REMOVED, AND THE PHYSICIAN RE-ACCESSED THE ARTERY. AN ADDITIONAL STENT WAS USED TO COVER THE DISSECTION, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.
Patient problems: Vascular Dissection
MAUDE report 24163696 ↗InjuryAug 6, 2025Material Integrity Problem; Failure to Deflate; Material Integrity Problem; Failure to Deflate
IT WAS REPORTED THAT THE ENFLATE BALLOON WOULD NOT DEFLATE, RESULTING IN ADDITIONAL INTERVENTION. AN ENROUTE ENFLATE TRANSCAROTID RX BALLOON DILATATION CATHETER WAS SELECTED FOR USE IN THE LEFT SIDED TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE. DURING REMOVAL, THE ENFLATE BALLOON WOULD NOT DEFLATE AND CAUSED A DISSECTION IN THE INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN USED A STIFF WIRE TO PUNCTURE THE BALLOON AND REMOVED IT OUT THROUGH THE ENROUTE ARTERIAL SHEATH. THE DISSECTION WAS TREATED WITH A PLANNED STENT. ADDITIONALLY, IT WAS ALSO REPORTED THAT UPON REMOVAL, THE SHAFT OF THE ENFLATE BALLOON WAS SPLIT IN HALF.
Patient problems: Vascular Dissection
MAUDE report 22730904 ↗
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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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