FATHOM™ -14 M001508140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729801047), received between Nov 15, 2019 and Feb 23, 2026 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 16, 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.

• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP DETACHMENT OCCURRED. A 300 CM X 10 CM FATHOM -14 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE END OF THE GUIDEWIRE DETACHED WHILE IN THE ARTERY AND WAS LEFT WITH THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24421469 ↗
• MalfunctionJan 14, 2026Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A FATHOM? -14 GUIDEWIRE WAS SELECTED FOR A PROCEDURE IN THE AORTA. DURING THE PROCEDURE, HOWEVER, THE WIRE FRACTURED AND A FRAGMENT WAS RETAINED WITHIN PATIENT'S AORTA. IT WAS IDENTIFIED AT THE TIME OF THE PROCEDURE. IT APPEARED TO BE IN A SAFE PLACE (INSIDE AORTIC SAC AND EXCLUDED FROM CIRCULATION BY AORTIC STENT GRAFT) THEREFORE THE COLLECTIVE INTRAPROCEDURAL DECISION WAS TO LEAVE IT IN SITU.

  Patient problems: Foreign Body In Patient

  MAUDE report 24068452 ↗
• MalfunctionOct 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE BROKE. THE PATIENT UNDERWENT AN INTERVENTIONAL RADIOLOGY PROCEDURE FOR CAROTID ARTERIOGRAM. A 300 CM X 10 CM FATHOM -14 WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE GUIDEWIRE BROKE PRIOR TO BEING INSERTED INTO THE BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20443279 ↗
• MalfunctionSep 17, 2024

  PATIENT IN INTERVENTIONAL RADIOLOGY FOR IR CAROTID ARTERIOGRAM: WIRE BROKE OFF PRIOR TO BEING INSERTED INTO THE BODY. NO PATIENT HARMS. PATIENT PRESENTED TO EMERGENCY IN RE CEREBROVASCULAR ACCIDENT DUE TO OCCLUSION OF RIGHT MIDDLE CEREBRAL ARTERY RESULTING IN ACUTE LEFT-SIDED WEAKNESS. ANGIOGRAPHY HEAD/NECK INDICATED. INTERVENTIONAL NEUROLOGY SUITE FOR CLOT RETRIEVAL, PATIENT ENDED UP GETTING TNKASE AND TAKEN TO INTERVENTIONAL SUITE FOR ATTEMPTED THROMBECTOMY. PATIENT HAD SIGNIFICANT EXTRACRANIAL RIGHT CAROTID STENOSIS REQUIRING ANGIOPLASTY AFTER WHICH PATIENT HAD ADEQUATE RIGHT MCA FLOW. NO THROMBECTOMY WAS PERFORMED. PATIENT EXTUBATED AND BROUGHT TO ICU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20236107 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A VESSEL DISSECTION OCCURRED. A 300 CM X 10 CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR BRONCHIAL ARTERY EMBOLIZATION. AFTER, THE PHYSICIAN SUCCESSFULLY CANNULATED BLEEDING VESSEL, THE VESSEL THEN DISSECTED AND PHYSICIAN FELT THIS WAS DEVICE RELATED. A FOLLOW UP WAS MADE WITH THE PATIENT AFTERWARDS AND THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18335483 ↗
• InjuryFeb 9, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE GUIDEWIRE WAS FRACTURED, REMAINED INSIDE PATIENT AND PROCEDURE WAS NOT COMPLETED. LAST DECEMBER 31,2022, THE PATIENT CAME TO HOSPITAL WITH A DISTURBANCE OF CONSCIOUSNESS. A 300CMX10CM FATHOM -14 WAS USED IN AN INTRACRANIAL ARTERIAL THROMBECTOMY. HOWEVER, THE GUIDEWIRE WAS FRACTURED WHEN USED FOR RAPID EXCHANGE. SUBSEQUENTLY, THE FRACTURED PART OF THE GUIDEWIRE REMAINED IN A BRANCH OF THE INTRACRANIAL MIDDLE CEREBRAL ARTERY AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT WAS SENT TO THE ICU WITHOUT PULLING OUT THE TUBE UNDER GENERAL ANESTHESIA. AT PRESENT, THE PHYSICIAN HAS NOT FOUND A WAY TO REMOVE THE REMAINING GUIDEWIRE. THE PATIENT WAS IN A COMA AFTER THE PROCEDURE, SUFFERED FROM WHITE LUNGS, AND WAS ON A VENTILATOR, ALL DUE TO COVID-19 INFECTION. CURRENTLY, THE PATIENT IS AWAKE, IS EXPERIENCING HEMIPLEGIA, AND HAS BEEN TRANSFERRED TO THE GENERAL WARD. IT WAS INDICATED THAT THE HOSPITAL WAS NOT ABLE TO PROVIDE THE REMAINING PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16335994 ↗
• InjuryJan 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE WAS BROKEN AND REMOVED WITH A SNARE. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 300CM X 10CM GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT WITHOUT ANY CAUSE THE DEVICE JUST BROKE OFF IN THE BODY. AFTERWARDS THE DEVICE WOULD NO LONGER FIT THROUGH THE RUBICON GUIDE CATHETER AND THEN DAMAGED THE RUBICON GUIDE CATHETER. A SNARE WAS USED TO GRAB THE BROKEN PART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16206544 ↗
• MalfunctionNov 15, 2019Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT TIP OF THE WIRE WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE INTRACRANIAL ARTERY. A 300CM X 10 CM FATHOM -14 WIRE WAS SELECTED FOR USE. AT THE END OF THE PROCEDURE, WHEN THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE TIP OF THE WIRE BECAME KINKED AND FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9328072 ↗