FATHOM™ -16 M001509000Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729764410), received between Nov 16, 2016 and Aug 7, 2024 — classified as 4 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
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE WIRE TIP WAS A LITTLE SPLIT. A 140X25CM FATHOM -16 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE TIP OF THE GUIDEWIRE WAS A LITTLE SPLIT. THE PROCEDURE WAS COMPLETED BY OPENING ANOTHER OF THE SAME GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19930385 ↗MalfunctionOct 4, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP FELL APART. A 140X25CM FATHOM -16 WAS SELECTED FOR USE. DURING PREPARATION, WHILE SHAPING, IT WAS NOTED THAT THE TIP FELL APART. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15539061 ↗MalfunctionMar 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT WIRE WAS SEPARATED. A 140X25CM FATHOM-16 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FLOPPY TIP OF THE DEVICE WAS FOUND TO BE SEPARATED FROM THE WIRE'S BODY. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE CATHETER WITH NO PATIENT CONSEQUENCES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8394712 ↗MalfunctionNov 16, 2016Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT GUIDE WIRE COATING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 140X25CM FATHOM" -16 GUIDE WIRE WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE WIRE WAS UNABLE TO MOVE FORWARD. THE DEVICE WAS PULLED BACK AND IT WAS FOUND OUT THAT THE SURFACE OF THE WIRE WAS HARSH AND COATING LOOKED LIKE IT WAS ALMOST TAKEN OFF, NOT COMPLETELY DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6107010 ↗
Other WIRE, GUIDE, CATHETER devices
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 1009664Abbott Vascular Inc. · WIRE, GUIDE, CATHETER321 reports
- SYNCHRO 14 M00313010Stryker Corporation · WIRE, GUIDE, CATHETER2 recalls220 reports
- 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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