FATHOM -16Recalls & reported problems across all models

We found 5 models of FATHOM -16 by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 121 adverse event reports in the FDA's MAUDE database, received between Nov 16, 2016 and Sep 2, 2026 — classified as 1 death, 33 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (60 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 -16 problems

FATHOM -16 models

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

• FATHOM™ -16 M001509100

  WIRE, GUIDE, CATHETER
  1 death105 reports
• FATHOM™ -16 M001509110

  WIRE, GUIDE, CATHETER
  7 reports
• FATHOM™ -16 M001509000

  WIRE, GUIDE, CATHETER
  4 reports
• FATHOM™ -16 M001509210

  WIRE, GUIDE, CATHETER
  3 reports
• FATHOM™ -16 M001509200

  WIRE, GUIDE, CATHETER
  2 reports

Recent FATHOM -16 adverse event reports

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

• MalfunctionSep 2, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569610 ↗
• MalfunctionJul 14, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE GUIDEWIRE FRACTURED OCCURRED. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING AN ANGIOGRAPHY PROCEDURE, A GUIDEWIRE WAS INTRODUCED INTO A MICROCATHETER. WHILE THE GUIDEWIRE WAS BEING ADVANCED THROUGH THE MICROCATHETER, SEPARATION OF THE GUIDEWIRE TIP WAS OBSERVED UNDER FLUOROSCOPY. NO RESISTANCE OR ENTRAPMENT WAS ENCOUNTERED PRIOR TO THE FRACTURE. THE GUIDEWIRE WAS REMOVED, HOWEVER, APPROXIMATELY HALF OF THE DETACHED TIP REMAINED WITHIN THE MICROCATHETER. THE DETACHED TIP WAS SUCCESSFULLY REMOVED FROM THE MICROCATHETER USING NEGATIVE PRESSURE WITH A 5 CC SYRINGE. A NEW FATHOM 16 GUIDEWIRE WAS THEN USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT FULLY RECOVERED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820977 ↗
• MalfunctionMar 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT # (B)(4) THAT TIP DETACHMENT OCCURRED. A 180X25CM GW FATHOM PERIPH WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE GUIDEWIRE SHEARED OFF INSIDE THE PATIENT'S HEPATIC ARTERY. THE WIRE END PORTION WAS LEFT INSIDE OF PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24562915 ↗
• MalfunctionFeb 17, 2026Fracture

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT #0504240000-2025-8016 THAT GUIDEWIRE FRACTURE OCCURRED, RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT. THE TARGET LESION WAS LOCATED IN THE HEPATIC PARENCHYMA. A 180X25CM FATHOM? -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, A SHORT SEGMENT OF THE THE GUIDEWIRE SHEARED OFF, AND APPEARED EMBEDDED IN THE PARENCHYMA, ADJACENT TO THE INTRAHEPATIC PORTAL VEIN. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24370078 ↗
• MalfunctionJan 20, 2026

  DURING A TIPS [TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT] PROCEDURE, A SHORT SEGMENT OF A 0.16 FATHOM MICROWIRE SHEARED OFF AND WAS RETAINED WITHIN THE HEPATIC PARENCHYMA. THIS WIRE FRAGMENT SHEARED FROM A 0.18" GUIDEWIRE AND APPEARED TO BE EMBEDDED IN THE LIVER PARENCHYMA ADJACENT TO THE INTRAHEPATIC PORTAL VEIN. PATIENT STABLE FOLLOWING PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24115655 ↗
• MalfunctionJan 15, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT KINK OCCURRED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS A BREAK AND A KINK NOTED 15CM IN THE DISTAL END OF THE GUIDEWIRE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT, 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 THE COATING IS PEELED AND BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24081674 ↗
• MalfunctionJan 12, 2026Unraveled Material; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT THE DISTAL END OF THE GUIDEWIRE APPEARED BROKEN. THE TARGET LESION WAS LOCATED IN THE LIVER. A 180X25CM FATHOM 16 WAS SELECTED FOR USE TO TREAT LIVER CANCER IN A Y-90 MAPPING PROCEDURE. DURING THE PROCEDURE, THE DISTAL END OF THE GUIDEWIRE APPEARED BROKEN BUT REMAINED INTACT. THE GUIDEWIRE WAS PULLED OUT OF THE PATIENT 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 A DETACHED DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24039229 ↗
• 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 11NOV2025. IT WAS REPORTED THAT WIRE WAS BENT. A 180X25CM FATHOM? 16 WAS SELECTED FOR USED. DURING UNPACKING, IT WAS NOTED THAT THE WIRE WAS BENT. THERE WERE NO COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING AT THE PROXIMAL SECTION WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810178 ↗
• MalfunctionDec 9, 2025Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 180 X 25 CM FATHOM-16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE WAS BROKEN. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761449 ↗
• MalfunctionNov 13, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. A 180 CM X 25 CM FATHOM?: 16 WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE, HOWEVER, THE TIP OF THE GUIDEWIRE DETACHED INSIDE THE PATIENT. AFTER RETRIEVING THE TIP, ANOTHER GUIDEWIRE HAD TO BE USED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23542435 ↗
• MalfunctionNov 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED A DEVICE COMPONENT DETACHED INSIDE OF THE PATIENT. A FATHOM 16 .016 PERPH GW 180X25CM GUIDEWIRE WAS SELECTED FOR A TRANSARTERIAL RADIOEMBOLIZATION (TARE) PROCEDURE. DURING THE PROCEDURE, THE DISTAL TIP OF THE FATHOM 16 .016 PERPH GW 180X25CM GUIDEWIRE DETACHED INSIDE OF THE PATIENT. THE DETACHED COMPONENT WAS REMOVED THROUGH A CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23513470 ↗
• InjuryNov 6, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. DURING A TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE INVOLVING THE LIVER, A 180 CM X 25 CM FATHOM-16 GUIDEWIRE WAS USED FOR SUPER-SELECTION. THE TARGET VESSEL EXHIBITED MODERATE TORTUOSITY AND NO CALCIFICATION. DURING USE, THE GUIDEWIRE FRACTURED WITHIN THE BLOOD VESSEL, SEPARATING INTO TWO PIECES. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE FRACTURED SEGMENT USING A CATCHER DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE, WITH NO REPORTED COMPLICATIONS OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23486852 ↗
• MalfunctionOct 15, 2025Entrapment of Device; Fracture; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Fracture; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WIRE STUCK AND FRACTURED OCCURRED. A 16 .016 PERPH GW 180X25CM FATHOM WAS SELECTED FOR USE IN A PSEUDO ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, THE WIRE DID NOT MAINTAIN ITS SHAPE AFTER MANUAL SHAPING. UPON INSERTION INTO THE MICROCATHETER, RESISTANCE WAS NOTED. WHEN THE FATHOM WIRE WAS SUBSEQUENTLY WITHDRAWN, IT INITIALLY APPEARED STUCK, THEN RELEASED ABRUPTLY AND FRACTURED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301257 ↗
• MalfunctionAug 15, 2025Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 22JUL2025. IT WAS REPORTED THAT TIP DAMAGE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE LIVER. A 180X25CM FATHOM? -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, A SMALL PROTRUSION OR IRREGULARITY WAS NOTED AT THE END OF THE DEVICE, WHICH PREVENTED IT FROM PROPERLY ENGAGING WITH THE TRUSELECT. AS A RESULT, THE DEVICE COULD NOT BE LOADED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING WITH AN ALTERNATE METHOD. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DETACHED AT DISTAL TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816837 ↗
• MalfunctionAug 1, 2025Unraveled Material; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUL2025. IT WAS REPORTED THAT THE WIRE WAS UNRAVELED. A 180X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE WIRE STARTED TO UNRAVEL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE POLYMER JACKER WAS PEELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686360 ↗

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