ENROUTE .014" Guidewire 11686-01 (REF SR-014-GW)Recalls & reported problems

Summary

The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 00811311020546), received between Mar 16, 2019 and Jul 17, 2025 — classified as 2 deaths, 100 injuries, 126 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (125 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 228 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2025Difficult to Advance; Difficult to Advance

  DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,PROCEDURE COMPLETED VIA ALTERNATIVE METHOD PATIENT OUTCOME: ADDITIONAL SURGERY EVENT DESCRIPTION: CAROTID ARTERY ACCESS WAS OBTAINED AND 8F ARTERIAL SHEATH WAS SUTURED IN PLACE FROM OUR ENROUTE NPS KIT. REVERSE FLOW TUBING WAS CONNECTED AND CAROTID WAS CLAMPED. THE ENROUTE 0.014 GUIDEWIRE WOULD NOT ADVANCE. DR. TOOK AN ANGIOGRAM AND A DISSECTION WAS NOTED. DR. COULD NOT GET THE GUIDEWIRE TO PASS THE DISSECTION PLANE AND STAY TRUE LUMEN, THEREFORE HE ELECTED TO CONVERT THE CASE TO CEA. PATIENT COMPLICATIONS: NO PATIENT COMPLICATIONS REASON FOR UNSUCCESSFUL PROCEDURE: REVERSE FLOW CONNECTED AND CAROTID ARTERY CLAMPED DISSECTION NOTED UPON ENTRY OF 0.014 WIRE AND PHYSICIAN COULD NOT PASS WIRE TO ENGAGE LESION, SO CONVERTED TO CEA.

  Patient problems: Vascular Dissection

  MAUDE report 22531355 ↗
• MalfunctionMay 21, 2025Difficult to Advance; Difficult to Advance

  ECN EVENT DESCRIPTION: NULL PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: OTHER PROVIDE DETAILS FOR "OTHER" PATIENT COMPLICATION: DISSECTION IN LCCA IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: UNKNOWN MEDICAL OR SURGICAL INTERVENTIONS: ADDITIONAL ENROUTE STENT USED TO COVER DISSECTION PATIENT OUTCOME: EXPECTED TO FULLY RECOVER.

  Patient problems: Vascular Dissection

  MAUDE report 22059732 ↗
• MalfunctionApr 25, 2025Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PHYSICIAN FAILED TO CROSS THE LESION WITH THE ENROUTE 0.14" GUIDEWIRE WHILE USING A BALLOON CATHETER FOR SUPPORT. WHEN EXCHANGING FOR ANOTHER 0.14" GUIDEWIRE, THE PHYSICIAN NOTED A PIECE OF THE ORIGINAL 0.14" GUIDEWIRE JUST OUTSIDE THE TIP OF THE 8F ENROUTE SHEATH. THE BROKEN WIRE PIECE WAS REMOVED THROUGH THE INCISION IN THE COMMON CAROTID ARTERY. ANOTHER 0.14" GUIDEWIRE WAS USED, AND THE PROCEDURE WAS COMPLETED WITH NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 21909339 ↗
• InjuryApr 9, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT AFTER A RIGHT TCAR PROCEDURE, THE PATIENT FAILED THE POST PROCEDURE NEUROCHECK AND COULDN'T MOVE THEIR LEFT ARM. ADDITIONAL INFORMATION STATED THAT THE PATIENT EXPERIENCED HYPOTENSION AFTER THE PROCEDURE, THE PATIENT WAS ON DAPT AND A P2Y12 TEST REVEALED THE PATIENT WAS THERAPEUTIC. IMAGING REVEALED THROMBUS IN THE STENT, AND THROMBECTOMY WAS PERFORMED. THE PATIENT HAS NOT RETURNED TO BASELINE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS DISSECTION IN THE DISTAL ICA NEAR THE PETROUS RIDGE, WHERE THE ENROUTE 014 WIRE INTERACTS.

  Patient problems: Vascular Dissection

  MAUDE report 21803525 ↗
• MalfunctionApr 2, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE HAD TROUBLE ADVANCING IN THE VESSEL DUE TO LESION CHARACTERISTICS. IMAGING REVEALED THE DISSECTION LIMITING FLOW PAST THE PROXIMAL ICA. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO CEA.

  Patient problems: Vascular Dissection

  MAUDE report 21750206 ↗
• MalfunctionApr 1, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT PRIOR TO A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PHYSICIAN IDENTIFIED A CLAMP INJURY ON A CTA FROM A PREVIOUS PROCEDURE. DURING TCAR PROCEDURE, WHILE CROSSING THE LESION, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. THE PHYSICIAN BELIEVES THAT THE DISSECTION WAS CAUSED BY THE CHALLENGING ANATOMY DUE TO THE CLAMP INJURY. THE PHYSICIAN ADDRESSED THE DISSECTION WITH THE PLANNED STENT AND COMPLETED THE PROCEDURE WITH NO HEALTH CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: Vascular Dissection

  MAUDE report 21737614 ↗
• MalfunctionApr 1, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. NO INTERVENTION WAS PERFORMED.

  Patient problems: Vascular Dissection

  MAUDE report 21736838 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT FAILED THE POST PROCEDURE NEUROLOGICAL CHECK AND COULDN'T MOVE THEIR LEFT ARM. ADDITIONAL INFORMATION STATED THAT THE PATIENT'S BLOOD PRESSURE DROPPED TO 85 SYSTOLIC AFTER THE PROCEDURE, THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) AND A P2Y12 PLATELET FUNCTION TEST REVEALED THE PATIENT WAS THERAPEUTIC. IMAGING REVEALED THROMBUS IN THE STENT, AND THROMBECTOMY WAS PERFORMED. THE PATIENT HAS NOT RETURNED TO BASELINE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS A POSSIBLE DISSECTION IN THE DISTAL INTERNAL CAROTID ARTERY (ICA) NEAR THE PETROUS RIDGE, WHERE THE 0.014" ENROUTE GUIDEWIRE INTERACTS. THE SILK ROAD MEDICAL EXECUTIVE MEDICAL DIRECTOR DISCUSSED THE EVENT WITH THE PHYSICIAN AND DETERMINED THAT THE REPORTED EVENT OF A THROMBOSED STENT LEADING TO AN EMBOLIC EVENT AND THROMBECTOMY WAS DUE TO THE DISSECTION CAUSED BY THE 0.014" ENROUTE GUIDEWIRE IN THE DISTAL ICA.

  Patient problems: Ischemia Stroke; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 21713599 ↗
• InjuryMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOURTEEN DAYS AFTER A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE PATIENT EXPERIENCED VISUAL DISTURBANCES. IMAGING REVEALED A NEW NARROWING NEAR THE DISTAL PORTION OF THE STENT, AND THE STENT REMAINED PATENT. THE PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET THERAPY (DAPT) AND A P2Y12 PLATELET FUNCTION TEST REVEALED THE PATIENT WAS THERAPEUTIC. FOLLOW UP IMAGING REVEALED A DISSECTION IN THE DISTAL PORTION OF THE STENTED AREA BELIEVED TO BE CAUSED BY THE 0.014" ENROUTE GUIDEWIRE, AND THROMBUS WAS OBSERVED IN THE DISSECTED AREA. AN ADDITIONAL STENT WAS PLACED TO RELINE THE AREA OF DISSECTION AND THE PATIENT HAS RETURNED TO BASELINE.

  Patient problems: Ischemia Stroke; Vascular Dissection; Visual Disturbances

  MAUDE report 21711981 ↗
• InjuryMar 14, 2025Adverse 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 0.014" ENROUTE GUIDEWIRE WAS BUCKLING AGAINST PLAQUE DURING ADVANCEMENT AND IMAGING REVEALED A DISSECTION. THE PHYSICIAN CONVERTED THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA). THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21610849 ↗
• InjuryMar 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.014" ENROUTE GUIDEWIRE CAUSED A DISSECTION WHILE CROSSING THE LESION. AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21565293 ↗
• MalfunctionMar 4, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION WHEN EXITING THE ARTERIAL SHEATH TIP. THE PHYSICIAN COMPLETED THE PROCEDURE AND AN ADDITIONAL STENT WAS PLACED TO ADDRESS THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 21512531 ↗
• InjuryMar 3, 2025Adverse 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 0.014" ENROUTE GUIDEWIRE CAUSED A DISSECTION WHEN EXITING THE ARTERIAL SHEATH TIP. AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21506128 ↗
• InjuryFeb 11, 2025Adverse 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 0.014" ENROUTE GUIDEWIRE PROLAPSED DURING ADVANCEMENT AND CAUSED A DISSECTION. A THIRD PARTY ANGLED CATHETER WAS USED TO ADVANCE THE ENROUTE GUIDEWIRE TO COMPLETE THE PROCEDURE. TWO UNPLANNED ADDITIONAL STENTS WERE PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21355500 ↗
• MalfunctionFeb 11, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE LOOPED WHEN EXITING THE ARTERIAL SHEATH AND CAUSED A DISSECTION. IMAGING REVEALED THE DISSECTION AT THE SHEATH TIP. THE PHYSICIAN USED ANOTHER ENROUTE 014 GUIDEWIRE TO COMPLETE THE PROCEDURE AND AN ADDITIONAL STENT WAS PLACED TO ADDRESS THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 21353570 ↗
• MalfunctionFeb 10, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE PROLAPSED DURING ADVANCEMENT AND CAUSED A DISSECTION. A 3RD PARTY ANGLED CATHETER (KUMPE) WAS USED TO ADVANCE THE WIRE AND THE PROCEDURE WAS COMPLETED. THE DISSECTION WAS ADDRESSED WITH TWO UNPLANNED ADDITIONAL STENTS.

  Patient problems: Vascular Dissection

  MAUDE report 21343333 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.014" ENROUTE GUIDEWIRE CAUSED A DISSECTION. AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21339535 ↗
• MalfunctionFeb 6, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. THE DISSECTION WAS ADDRESSED WITH AN UNPLANNED ADDITIONAL STENT.

  Patient problems: Vascular Dissection

  MAUDE report 21320431 ↗
• InjuryFeb 5, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING A LEFT TRANSCAPHOID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE 0.014" ENROUTE GUIDEWIRE LOOPED WHEN EXITING THE ARTERIAL SHEATH RESULTING IN A DISSECTION AT THE SHEATH TIP. THE PHYSICIAN USED ANOTHER 0.014" ENROUTE GUIDEWIRE TO COMPLETE THE PROCEDURE AND AN UNPLANNED ADDITIONAL STENT WAS PLACED TO COVER THE DISSECTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21314754 ↗
• MalfunctionFeb 4, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSAORTIC ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A PERFORATION. THE PHYSICIAN PLACED 2 ADDITIONAL STENTS TO ADDRESS THE PERFORATION. IMAGING AFTER STENT DEPLOYMENT REVEALED THE PERFORATION HAD NOT RESOLVED AND WAS CAUSING DISRUPTIONS IN FLOW THROUGH THE STENTS. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO CEA AND THE STENTS WERE EXPLANTED.

  Patient problems: Perforation of Vessels

  MAUDE report 21301485 ↗
• InjuryJan 24, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A RIGHT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 0.014" GUIDEWIRE CAUSED A PERFORATION. ADDITIONALLY, THE PHYSICIAN REPORTED THAT THE LESION WAS DIFFICULT TO CROSS AND MULTIPLE THIRD-PARTY WIRES WERE USED. THE PHYSICIAN PLACED TWO ADDITIONAL STENTS TO ADDRESS THE PERFORATION. HOWEVER, IMAGING AFTER STENT DEPLOYMENT REVEALED THAT THE PERFORATION HAD NOT RESOLVED AND WAS CAUSING DISRUPTIONS IN FLOW THROUGH THE STENTS. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO CAROTID ENDARTERECTOMY (CEA), EXPLANT THE STENTS, AND TACK DOWN THE INTIMA DISTALLY.

  Patient problems: Perforation

  MAUDE report 21234026 ↗
• MalfunctionJan 20, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. NO INTERVENTION WAS PERFORMED AS IT WAS A SELF RESOLVING DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 21189605 ↗
• MalfunctionJan 17, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. THE PROCEDURE WAS CONVERTED TO CEA.

  Patient problems: Vascular Dissection

  MAUDE report 21177413 ↗
• MalfunctionJan 17, 2025Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT DURING A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 014 GUIDEWIRE CAUSED A DISSECTION. THE DISSECTION WAS ADDRESSED WITH AN UNPLANNED ADDITIONAL STENT.

  Patient problems: Vascular Dissection

  MAUDE report 21177358 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LEFT TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE, THE ENROUTE 0.014" GUIDEWIRE CAUSED A DISSECTION. THE DISSECTION WAS ADDRESSED WITH AN UNPLANNED ADDITIONAL STENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Vascular Dissection

  MAUDE report 21081863 ↗