VIA Microcatheter VIA-21-154-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00851566003918), received between Apr 23, 2019 and Oct 30, 2020 — classified as 2 deaths, 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WITH A WEB DEVICE WAS ATTEMPTED FOR AN UNRUPTURED ACOM ANEURYSM. DURING THE ADVANCEMENT OF THE IMPLANT THROUGH A VIA MICROCATHETER, THE ANEURYSM WAS PERFORATED BY THE MICROCATHETER BEFORE DEPLOYMENT OF THE IMPLANT. THE SYSTEM WAS REMOVED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BALLOON ASSISTED COILING AND EVD. THE PATIENT HAD NO NEUROLOGICAL DEFICITS AND WAS REPORTED TO BE STABLE, POST-PROCEDURE. THERE WAS NO REPORTED MALFUNCTION OF THE VIA.

  Patient problems: Ruptured Aneurysm

  MAUDE report 10765376 ↗
• InjuryAug 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR A RUPTURED PERICALLOSAL ARTERY BIFURCATION ANEURYSM. THE VIA WAS TRACKED THROUGH A VESSEL THAT WAS REPORTED TO HAVE A 90-DEGREE ANGLE COURSING A SHORT A1 SEGMENT TO GET TO THE NECK OF THE ANEURYSM. THE FIRST WEB SELECTED FOR THE ANEURYSM WAS TOO LARGE, SO IT WAS REMOVED THROUGH THE VIA WITHOUT INCIDENT; HOWEVER, THE VIA WAS NOT IN THE PROPER LOCATION FOR PLACEMENT OF THE SMALLER WEB AND NEEDED TO BE TRACKED BACK UP. AFTER SUCCESSFUL DEPLOYMENT OF THE WEB IN THE ANEURYSM, A SLIGHT "DISSECTION" WAS NOTED IN SUBSEQUENT ANGIOGRAMS AT THE LOCATION OF THE 90-DEGREE ANGLE IN THE VESSEL. AFTER WAITING APPROXIMATELY FIVE (5) MINUTES, ADDITIONAL ANGIOGRAMS WERE TAKEN AND THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. NO ADDITIONAL INTERVENTION WAS PERFORMED. THERE WAS NO REPORTED SEQUELA.

  Patient problems: Vascular Dissection

  MAUDE report 10411605 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE TREATING A MIDDLE CEREBRAL ARTERY BIFURCATING ANEURYSM WITH A WEB DEVICE, THE ANEURYSM WAS RUPTURED WITH A GUIDEWIRE AND A VIA 21 MICROCATHETER DURING ATTEMPTS TO ACCESS THE ANEURYSM PRIOR TO THE INTRODUCTION OF THE WEB. THE CASE WAS TERMINATED AT THAT POINT.

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 9507914 ↗
• DeathNov 8, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED FOR AN UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE VESSEL WAS REPORTED TO BE TORTUOUS. AN ATTEMPT WAS MADE TO RETRACT THE WEB DEVICE INTO THE VIA MICROCATHETER FOR REPOSITIONING IN THE ANEURYSM. ADDITIONAL FORCE WAS REQUIRED TO RECAPTURE THE WEB INTO THE VIA DUE TO THE VESSEL TORTUOSITY AND THE ANGLE OF THE MICROCATHETER IN RELATION TO THE PROXIMAL MARKER OF THE WEB DEVICE. AT THE TIME THE WEB WAS WITHDRAWN INTO THE VIA, THE VIA "JUMPED" FORWARD. THE MICROCATHETER WAS PULLED BACK AND AN ANGIOGRAPHY RUN DEMONSTRATED CONTRAST EXTRAVASATION FROM THE ANEURYSM. HEPARIN WAS REVERSED AND PROTAMINE WAS ADMINISTERED. THE VIA AND WEB WERE REMOVED TOGETHER, A NEW MICROCATHETER WAS PLACED, AND THREE (3) EMBOLIZATION COILS WERE IMPLANTED IN THE ANEURYSM, WHICH STOPPED THE BLEEDING; HOWEVER, THE PATIENT DEVELOPED INTRACRANIAL HYPERTENSION DURING THE PROCEDURE, AND BOTH PUPILS WERE NOTED TO BE DILATED AND UNRESPONSIVE. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS PLACED AND THE PATIENT WAS ADMITTED TO THE ICU. THE PATIENT NEVER REGAINED CONSCIOUSNESS AND DIED FOUR DAYS LATER. THE CAUSE OF DEATH WAS DETERMINED BY THE PHYSICIAN TO BE "HIGH INTRACRA

  Patient problems: Death; Hemorrhage, Cerebral; Rupture

  MAUDE report 9298509 ↗
• DeathOct 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TREATMENT WAS PERFORMED ON A PATIENT WITH RUPTURED ANEURYSMS AND A DUAL HEMORRHAGIC STROKE INVOLVING THE DISTAL ANTERIOR CEREBRAL ARTERY (ACA) AND THE POSTERIOR COMMUNICATING ARTERY (PCOM) ON THE SAME SIDE. AFTER SUCCESSFUL IMPLANTATION OF TWO WEB DEVICES AND STASIS OF BOTH ANEURYSMS, THE FINAL ANGIOGRAPHY RUN DEMONSTRATED CLOT FORMING ON THE INTERMEDIATE CATHETER (NON-MV DEVICE) AND THE VIA MICROCATHETER IN THE A2 ARTERY. THE VIA WAS REMOVED, AND ASPIRATION AND MECHANICAL THROMBECTOMY WERE PERFORMED. EXTRAVASATION WAS THEN NOTICED IN THE INTERNAL CAROTID ARTERY AND PCOM ORIGIN. THE WEB IN THE PCOM ANEURYSM APPEARED TO BE INTACT WITH NO VISIBLE DEFORMATIONS. A BALLOON WAS INFLATED AT THE SITE OF EXTRAVASATION, WHICH REDUCED THE BLEEDING. THE PATIENT WAS ADMITTED TO THE ICU. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY ONE WEEK POST-PROCEDURE; HOWEVER, THE CAUSE AND EXACT DATE OF THE PATIENT'S DEATH ARE UNKNOWN. THE PHYSICIAN DID NOT CONSIDER THERE TO HAVE BEEN A MALFUNCTION OR ISSUE WITH A MICROVENTION DEVICE.

  Patient problems: Death; Extravasation; Hemorrhage, Cerebral; Rupture; Thrombus

  MAUDE report 9264704 ↗
• InjurySep 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF A MIDDLE CEREBRAL ARTERY ANEURYSM, THE MICROCATHETER RUPTURED THE DOME OF THE ANEURYSM. A WEB DEVICE WAS BEING ADVANCED THROUGH THE MICROCATHETER AT THE TIME. THE PATIENT WAS TREATED WITH BALLOON REMODELING AND SIX EMBOLIZATION COILS. AFTER EXTUBATION, THE PATIENT WAS REPORTED TO HAVE NO COGNITIVE IMPAIRMENT AND WAS MOVING BOTH SIDES OF THE BODY.

  Patient problems: Rupture

  MAUDE report 9090578 ↗
• InjurySep 14, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT TREATMENT WAS ATTEMPTED ON AN ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOM) WHICH HAD AN ACUTE TAKEOFF ANGLE FROM THE PARENT ARTERY. AFTER MULTIPLE ATTEMPTS, THE MICROCATHETER FINALLY GAINED ACCESS TO THE ANEURYSM FROM THE RIGHT INTERNAL CAROTID ARTERY (ICA); HOWEVER, THE WEB DEVICE WAS NOT OPENING ADEQUATELY, DESPITE SEVERAL DEPLOYMENT ATTEMPTS. THE MICROCATHETER AND WEB DEVICE WERE REMOVED. A NEW VIA 21 MICROCATHETER WAS SUCCESSFUL AT OBTAINING ACCESS TO THE ANEURYSM FROM THE LEFT ICA. DEPLOYMENT OF THE SAME WEB DEVICE WAS ATTEMPTED, BUT EFFORTS WERE UNSUCCESSFUL DUE TO DIFFICULT ANATOMY. DURING PARTIAL DEPLOYMENT OF THE WEB, A NEW ROADMAP IMAGE WAS OBTAINED, WHICH DEMONSTRATED AN ANEURYSM RUPTURE WITH CONTRAST EXTRAVASATION. THE WEB DEVICE WAS REMOVED AND THE ANEURYSM WAS PARTIALLY COILED THROUGH THE VIA MICROCATHETER, WHICH WAS EFFECTIVE AT CONTROLLING THE BLEEDING; HOWEVER, CHANGES IN THE PATIENT'S VITAL SIGNS WERE INDICATIVE OF A SUBARACHNOID HEMORRHAGE. THE ANEURYSM TREATMENT WAS STOPPED AT THIS POINT SO THAT AN EVD COULD BE PLACED. THE PATIENT WAS STABLE AT THE END OF THE PROCEDURE. THE PATIENT IS REPORTED TO HAVE RECOVERED AND THE ANEURYSM WAS RETREATE

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 9056904 ↗
• InjuryApr 23, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT DURING TREATMENT FOR A BASILAR ARTERY APEX ANEURYSM, A 6F NEUROMAX GUIDING SHEATH AND A SOFIA CATHETER WERE USED TOGETHER WITH THE VIA 21 MICROCATHETER. AFTER INITIAL PLACEMENT OF THE CATHETERS, THERE WAS A PAUSE IN FLUOROSCOPY AND UPON RESUMING FLUORO, DIGITAL ROAD MAPPING IMAGES DEMONSTRATED MOVEMENT OF THE VIA CATHETER. SUBSEQUENT ANGIOGRAPHY DEMONSTRATED CONTRAST EXTRAVASATION FROM THE DOME OF THE ANEURYSM WITH RESULTING SUBARACHNOID HEMORRHAGE. HEPARIN WAS REVERSED AND THE VIA 21 WAS REMOVED AND REPLACED WITH AN SL-10 MICROCATHETER, AND AN OCCLUSION BALLOON WAS POSITIONED IN THE BASILAR ARTERY TO PREVENT BLOOD FLOW TO THE ANEURYSM. EMBOLIZATION COILS WERE THEN DEPLOYED IN THE ANEURYSM AND SUBSEQUENT ANGIOGRAPHY CONFIRMED THAT BLEEDING HAD STOPPED. AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED TO RELIEVE/MONITOR INTRACRANIAL PRESSURES. IT WAS REPORTED THAT PATIENT HAD NO STROKE, BUT HAD SIGNIFICANT EDEMA IN THE BRAIN. THE PATIENT WAS TAKEN TO THE ICU AND HAS BEEN KEPT HEAVILY SEDATED SINCE THE PROCEDURE TO PREVENT PATIENT MOVEMENT AND BRAIN SWELLING.

  Patient problems: Hemorrhage, Subarachnoid; Rupture

  MAUDE report 8542393 ↗