FATHOM™ -16 M001509110Recalls & reported problems
Boston Scientific Corporation · Steerable Guidewire · Class 2
All models of FATHOM -16 (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729762560), received between Oct 18, 2018 and Sep 2, 2026 — classified as 1 injury, 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component3
- Fracture3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Difficult to Insert1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 7 most recent of 7 reports, 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 ↗MalfunctionApr 3, 2025Fracture; Difficult to Insert; Fracture; Difficult to Insert
IT WAS REPORTED THAT TIP FRACTURE OCCURRED. A 180X35CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP WAS DELAMINATED WHEN PULLED OUT OF ITS LOOP AND COULD NOT BE INSERTED INTO THE HUB OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21763477 ↗MalfunctionFeb 8, 2024Detachment 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 TIP DETACHMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR LIVER METASTASES AND UNDERWENT BLAND EMBOLIZATION. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED VESSEL. A180X35CM FATHOM -16 GUIDEWIRE WAS ADVANCED; HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE TIP BROKE OFF. THE TIP WAS HELD TOGETHER BY AN INTERNAL THREAD AND WAS PULLED BACK INTO THE MICROCATHETER AND WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER GUIDEWIRE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18672465 ↗MalfunctionJun 11, 2021Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THAT THE COATING OF THE GUIDEWIRE WAS COMING OFF. A FATHOM 16 .016, 180X35CM, PERIPHERAL GUIDEWIRE WAS SELECTED FOR USE IN A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE IN THE LIVER. WHILE RETRACTING THE WIRE BACK THROUGH THE INTRODUCER NEEDLE, IT WAS REPORTED THAT THE COATING OF THE FATHOM WAS COMING OFF. IT WAS CONFIRMED THAT NO COATING AND/OR FRAGMENTS WERE LEFT INSIDE THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11985198 ↗MalfunctionFeb 24, 2020Fracture; Fracture
IT WAS REPORTED THAT A GUIDEWIRE FRACTURE OCCURRED. A 180X35CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE FATHOM WIRE WAS SPLIT. THE PHYSICIAN REVEALED THAT THE SAME ISSUE HAPPENED TWICE. NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9744596 ↗InjuryJan 21, 2020Fracture; Fracture
IT WAS REPORTED THAT WIRE SHEARED OFF VIA VOLUNTARY MEDWATCH MW5091859. A 180X35CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING THE STENT INSERTION TO THE RIGHT SIDE NEPHROURETERAL, IT WAS NOTED THAT A SMALL FRAGMENT OF THE WIRE SHEARED OFF. THE WIRE COULD NOT BE RETRIEVED FROM THE COLLECTING SYSTEM. THE FRAGMENT WILL BE REMOVED DURING A NEPHROLITHOTOMY PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 9610670 ↗MalfunctionOct 18, 2018Break; Break
IT WAS REPORTED THAT THE COATING OF THE DEVICE BROKE. A 180X35CM FATHOM 16 WAS SELECTED FOR USE. A BREAK OF THE COATING AT THE TIP OF THE DEVICE WAS NOTED UPON OPENING THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7979727 ↗
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- PressureWire™ C12059Lightlab Imaging, Inc. · WIRE, GUIDE, CATHETER1 death296 reports
- SYNCHRO 2 M00326410Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls155 reports
- ENROUTE .014" Guidewire 11686-01Silk Road Medical, Inc. · Wire, Guide, Catheter2 deaths228 reports
- ARROW IPN035915Teleflex Incorporated · WIRE, GUIDE, CATHETER217 reports
- OmniWire Pressure guide wire 89185Philips Image Guided Therapy Corporation · Wire, Guide, Catheter1 recall1 death160 reports
- ARROW IPN055780Teleflex Incorporated · Wire, guide, catheter4 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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