FATHOM™ -14 M001508150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729801054), received between Sep 9, 2022 and Aug 19, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324068 ↗
• MalfunctionNov 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE TIP BROKE OFF. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS VESSEL. A 300CM X 10CM FATHOM -14 GUIDEWIRE WAS ADVANCED FOR THE EMBOLIZATION PROCEDURE. AFTERWARD, THE WIRE WAS REMOVED. WHEN ATTEMPTING TO REINTRODUCE THE WIRE, IT WAS NOTED THAT THE FLOPPY TIP BROKE OFF. THE DEVICE WAS IN ONE PIECE WHEN IT WAS REMOVED FROM THE PATIENT. A NEW WIRE WAS OPENED AND COMPLETED THE PROCEDURE. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20786182 ↗
• MalfunctionAug 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A 300CM X 10CM FATHOM -14 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DISTAL TIP OF THE WIRE FRACTURED WHILE THE PHYSICIAN WAS SPINNING IT DURING THE PROCEDURE. A HAIR-LIKE FIBER IS KEEPING THE TIP FROM COMPLETE SEPARATION, SO THE DEVICE WAS COMPLETELY PULLED OUT. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973623 ↗
• MalfunctionMar 20, 2024Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27-FEB 2024. IT WAS REPORTED THAT GUIDEWIRE KINK OCCURRED. THE PATIENT UNDERWENT A STENT IMPLANTATION ON THE SUPERIOR MESENTERIC ARTERY. THE LEFT GROIN WAS PUNCTURED, AND A 300CM X 10CM FATHOM PERIPH GUIDEWIRE WAS COMBINED WITH A 4F VERTEBRAL ARTERY CATHETER FOR THE TREATMENT. THE GUIDEWIRE WAS SUPERSELECTED TO THE DISTAL END OF THE ARTERY AND A 9X50 CAROTID STENT WAS DELIVERED TO PREPARE FOR DEPLOYMENT. DURING THE PROCEDURE, THE STENT WAS DELIVERED TO THE ABDOMINAL AORTA, BUT COULD NOT GO FURTHER. THE GUIDEWIRE WAS TAKEN OUT AND FOUND TO HAVE BEEN KINKED, CAUSING THE FAILURE TO CROSS. THE DEVICE WAS REPLACED BY ANOTHER OF THE SAME MODEL TO SUCCESSFULLY DEPLOY THE STENT AND TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED, AND PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE GUIDEWIRE WAS PEELED AT POLYMER JACKET SECTION AND KINKED AT WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18943544 ↗
• MalfunctionSep 9, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE SEPARATE GUIDEWIRE TIPS HAD FRACTURED DURING USE. A 300CMX10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE TIP FRACTURED AND ABOUT 10CM HAD TORN OFF AND REMAINED IN THE VESSEL. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP WITH A SNARE KIT. THE PHYSICIAN AGAIN ATTEMPTED WITH TWO ADDITIONAL FATHOM-14 GUIDEWIRES (300X10CM, 200X10CM), HOWEVER BOTH TIPS FRACTURED/STRETCHED LEAVING THE TIP NEARLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395715 ↗
• InjurySep 9, 2022Detachment 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 THREE SEPARATE GUIDEWIRE TIPS HAD FRACTURED DURING USE. A 300CMX10CM FATHOM-14 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE TIP FRACTURED AND ABOUT 10CM HAD TORN OFF AND REMAINED IN THE VESSEL. THE PHYSICIAN WAS ABLE TO REMOVE THE TIP WITH A SNARE KIT. THE PHYSICIAN AGAIN ATTEMPTED WITH TWO ADDITIONAL FATHOM-14 GUIDEWIRES (300X10CM, 200X10CM), HOWEVER BOTH TIPS FRACTURED/STRETCHED LEAVING THE TIP NEARLY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT SEQUELA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395254 ↗