FATHOM -14Recalls & reported problems across all models

We found 4 models of FATHOM -14 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2018 and Sep 23, 2026 — classified as 30 injuries, 84 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (44 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FATHOM -14 problems

FATHOM -14 models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FATHOM™ -14 M001508110

  WIRE, GUIDE, CATHETER
  57 reports
• FATHOM™ -14 M001508100

  WIRE, GUIDE, CATHETER
  43 reports
• FATHOM™ -14 M001508140

  WIRE, GUIDE, CATHETER
  8 reports
• FATHOM™ -14 M001508150

  WIRE, GUIDE, CATHETER
  6 reports

Recent FATHOM -14 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Entrapment of Device; Detachment of Device or Device Component

  It was reported that the guidewire fractured inside the microcatheter during insertion.A 200 cm X 10 cm FATHOM? -14 guidewire was selected for use in a Y-90 mapping procedure. The guidewire had been shaped five to six times prior to use. While inserting the guidewire into a 2.4F non-Boston Scientific (BSC) microcatheter, the guidewire felt crunchy. An attempt was made to take the guidewire out of the microcatheter, but the guidewire became stuck within the microcatheter and broke apart. The guidewire fractured into two pieces; both pieces were removed. The procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868761 ↗
• MalfunctionAug 24, 2026Detachment of Device or Device Component; Difficult to Advance

  It was reported that tip detachment occurred.The patient underwent transcatheter internal iliac artery embolization for bladder hemorrhage. A 200cm x 10cm Fathom-14 guidewire was selected for use. However, during the procedure, while advancing the guidewire through the microcatheter under digital subtraction angiography (DSA) guidance, the tip of the guidewire remained stationary despite multiple attempts to advance it. The guidewire and microcatheter were withdrawn together. Upon external inspection, it was noted that the guidewire tip was detached. The device was removed, and the procedure was completed with another of the same device. There were no patient complications as a result of this event, and the patient was stable post-procedure.It was further reported that the target lesion was non-stenosed, non-tortuous, and non-calcified.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50400843 ↗
• MalfunctionAug 19, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324068 ↗
• MalfunctionAug 14, 2026Stretched; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50260544 ↗
• MalfunctionJul 28, 2026Fracture; Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059834 ↗
• 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 ↗
• MalfunctionJan 12, 2026Deformation Due to Compressive Stress; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT TRACKING DIFFICULTY OCCURRED. DURING A GENICULAR ARTERY EMBOLIZATION, A 14, 200 CM X 10 CM FATHOM GUIDEWIRE WAS SELECTED FOR USE. IT WAS ATTEMPTED TO ADVANCE THE MICROWIRE THROUGH THE 155CM TRUSELECT MICROCATHETER, BUT INCREASED RESISTANCE WAS NOTICED. THE MICROCATHETER WAS REMOVED, RE-FLUSHED, AND THE MICROWIRE WAS ADVANCED AGAIN, BUT THE SAME RESISTANCE WAS ENCOUNTERED. IT WAS ATTEMPTED TO REMOVE THE MICROWIRE AGAIN, BUT BOTH MICROCATHETER AND MICROWIRE STARTED TO BUNCH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE COATING WAS PEELED,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048084 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON UNPACKING, IT WAS DISCOVERED THAT THE OUTER MEMBRANE OF THE DEVICE WAS PARTIALLY TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816725 ↗
• MalfunctionDec 15, 2025Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2025. IT WAS REPORTED THAT TIP OF THE GUIDEWIRE WAS BENT AND KINKED. A 200CM X 10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE IN THE ABDOMINAL CAVITY FOR A PERITONEOGRAPHY. DURING THE PROCEDURE, THE GUIDEWIRE ENTERED THE SHEATH, AND IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE BENT AND KINKED AND COULD NOT BE SMOOTHLY DELIVERED. THE GUIDEWIRE WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PTFE COATING AT THE PROXIMAL SECTION OF THE GUIDEWIRE WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810175 ↗
• InjuryNov 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A GUIDEWIRE FRACTURE AND DETACHMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE PATIENT WAS ON MEDICATION. DURING A PROCEDURE USING A NON-BOSTON SCIENTIFIC REVERSED CURVED CATHETER IN VERY TORTUOUS ANATOMY, THE PHYSICIAN PERFORMED TWO 180-DEGREE TURNS TO ADVANCE THE DEVICE. A 200 CM X 10 CM FATHOM-14 GUIDEWIRE WAS INTRODUCED AND MANIPULATED WITHIN THE CATHETER. DURING THIS PROCESS, APPROXIMATELY 6 CM OF THE GUIDEWIRE SNAPPED OFF FROM THE BACK END WHILE INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED RETRIEVAL BY ADVANCING AND RETRACTING THE MICROCATHETER, AS WELL AS PULLING BACK AND ASPIRATING, BUT THE FRAGMENT REMAINED LODGED. IT WAS BELIEVED THAT VASOSPASM OCCURRED, PREVENTING FURTHER MOVEMENT. THE SEPARATED PORTION WAS THOUGHT TO HAVE BECOME LODGED IN A PELVIC SIDEWALL BRANCH NEAR THE UPPER GASTRIC REGION. THE VESSEL WAS NOTED TO HAVE SPASM BUT WAS NOT SIGNIFICANTLY CALCIFIED. THE PHYSICIAN DID NOT ANTICIPATE ANY ADVERSE EFFECTS FROM THE RETAINED FRAGMENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT, WHO WAS ON ANTICOAGULATION THERAPY, IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient; Vasoconstriction

  MAUDE report 23542286 ↗
• MalfunctionOct 30, 2025Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02OCT2025. IT WAS REPORTED THAT DIFFICULTY ADVANCING OCCURRED. A 200CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE FOR INTERVENTIONAL THERAPY FOR LIVER CANCER. DURING ADVANCING, THE WIRE WAS NOT SMOOTH. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHMENT AT THE DISTAL TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23427524 ↗
• MalfunctionSep 22, 2025Stretched; Detachment of Device or Device Component; Stretched; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 200CM X 10CM GW FATHOM-14, ANGLED TIP GUIDEWIRE WAS SELECTED FOR EMBOLIZATION OF INTRACRANIAL ANEURYSM. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE WAS FRACTURED WHEN IT REACHED THE MIDDLE CEREBRAL ARTERY. THE LENGTH OF THE FRACTURED GUIDEWIRE WAS APPROXIMATELY 7CM. THE GUIDEWIRE WAS SIMPLY PULLED OUT, AND THE FRACTURED GUIDEWIRE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME GUIDEWIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110020 ↗
• MalfunctionAug 21, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28AUG2025. IT WAS REPORTED THAT DEVICE DIFFICULT TO TRACK OVER WIRE AND TIP DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL CAVITY. A 200CM X 10CM FATHOM-14 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN GUIDEWIRE ENTERED THE LESION. THE TIP WAS WEAK AND COULD NOT GUIDE. THE GUIDEWIRE WAS WITHDRAWN, AND IT WAS NOTED THAT THE TIP WAS TORTUOUS AND DEFORMED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DISTAL TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866076 ↗
• MalfunctionJul 25, 2025Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED. A 200 CM X 10 CM FATHOM? -14 GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, THERE WAS NO RESISTANCE, BUT THE GUIDEWIRE SHEARED OR FRACTURED. IT APPEARS THAT THE GUIDEWIRE MAY HAVE BEEN DAMAGED PRIOR TO BEING FULLY REMOVED FROM ITS PLASTIC CASING. PEELED COATING WAS NOTICED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22613836 ↗

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