NEUROSCOUT 601-314Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886704028376), received between Mar 29, 2019 and Apr 21, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Unsealed Device Packaging; Unsealed Device Packaging

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN OPENED THE OUTER PACKAGE OF THE 0.014IN. X 205CM NEUROSCOUT 14 STANDARD GUIDEWIRE (601314 / JA2077) FOR INSPECTION AND FOUND THAT THE INNER STERILE PACKAGING WAS OPEN. THE DEVICE WAS NOT USED IN THE PATIENT. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. PHOTOS WERE INCLUDED IN THE COMPLAINT. THE PHOTOS ARE OF THE PRODUCT PACKAGING BOX AND PRODUCT POUCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14177632 ↗
• InjurySep 14, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO TREAT AN INTRACRANIAL ARTERY STENOSIS IN THE PATIENT WHO WAS IMPLANTED WITH AN ENTERPRISE STENT (ABOUT TWO YEARS PRIOR), THE PHYSICIAN TRIED TO PASS THE 0.014 IN. X 205 CM NEUROSCOUT 14 STANDARD GUIDEWIRE (601314 / J6918N) THROUGH THE PREVIOUSLY IMPLANTED STENT, AND HE FELT A LITTLE FORCE, BUT HE THOUGHT IT WAS WITHIN ¿REASONABLE SCOPE.¿ AFTER ABOUT 6 CM OF THE GUIDEWIRE TIP CAME INTO THE STENT, THE GUIDEWIRE FRACTURED AND SEPARATED 13CM FROM ITS DISTAL TIP. THE DETACHED SEGMENT OF THE GUIDEWIRE EMBOLIZED IN THE MIDDLE CEREBRAL ARTERY (MCA). THIS PROMPTED THE USE OF A COMPETITOR STENT RETRIEVER TO REMOVE THE DETACHED SEGMENT OF THE GUIDEWIRE FROM THE PATIENT. THE EVENT RESULTED IN AN APPROXIMATELY ONE-HOUR PROCEDURAL DELAY. THERE WAS NO OBSERVABLE CLINICAL SYMPTOMS OR CHANGES IN SYMPTOMS IDENTIFIED IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR GUIDEWIRE. IMAGING FROM THE PROCEDURE WAS INCLUDED AND WAS FORWARDED TO INDEPENDENT PHYSICIAN FOR REVIEW ON (B)(6) 2020. ¿THE COMPLAINT FORM IS ACCOMPANIED BY A FLUOROSCOPIC IMAGE OF THE WIRE IN THE PATIENT AND A PHOTO OF THE WIRE FRAGMENT. THE PHYSICIAN REPORTS

  Patient problems: No Code Available

  MAUDE report 10532235 ↗
• MalfunctionMar 29, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A NON-TORTUOUS PERICALLOSAL ARTERY ANEURYSM, THE 6F ENVOY DA GUIDE CATHETER WAS POSITIONED AND THE PROWLER SELECT LPES (606S155FX/17680646) MICROCATHETER AND NEUROSCOUT 14 STD (601314/HU8939) GUIDEWIRE WERE INTRODUCED, BUT THE GUIDEWIRE BECAME IMPEDED IN THE BODY/SHAFT OF THE MICROCATHETER NEAR THE SITE OF THE ANEURYSM AND THE PHYSICIAN WAS UNABLE TO REMOVE THE GUIDEWIRE FROM THE MICROCATHETER. MANEUVERS WERE MADE IN AN ATTEMPT TO ¿DROP¿ THE GUIDEWIRE FROM INSIDE OF THE MICROCATHETER, BUT THE PHYSICIAN ULTIMATELY DECIDED TO WITHDRAW THE GUIDEWIRE AND MICROCATHETER FROM THE GUIDE CATHETER AS A UNIT. UPON REMOVAL, THE PHYSICIAN NOTICED THAT THE GUIDEWIRE WAS TRAPPED INSIDE OF THE MICROCATHETER AND THE DEVICES WERE ¿FIXED¿. THE GUIDEWIRE AND MICROCATHETER WERE REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME ENVOY GUIDE CATHETER. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE LENGTH OF TIME THAT THE SURGERY WAS DELAYED DUE TO THE EVENT WAS NOT REPORTED; HOWEVER, THE DELAY WAS NOT CONSIDERED CLINICALLY SIGNIFICANT. THE DEVICES WERE STORED, PREPPED, AND FLUSHED ACCORDING TO THE I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464256 ↗