FATHOM™ -16 M001509200Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729961116), received between Dec 8, 2022 and Nov 14, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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 Component1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 14, 2024Fracture; Fracture
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS AND MILDLY CALCIFIED POSTERIOR SEGMENTAL BRANCH OFF THE RENAL ARTERY. A 200X25CM FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE. DURING REMOVAL, IT WAS NOTED THAT THE PART OF THE WIRE BROKE OFF INSIDE THE CATHETER AND AN ESTIMATED 10CM PORTION OF THE WIRE BROKE INSIDE THE PATIENT. A HEADLINER NON-BOSTON SCIENTIFIC WIRE WAS USED TO WEDGE IT IN BETWEEN THE FRAGMENTED FATHOM AND WAS ABLE TO LATCH ONTO THE FATHOM WIRE AND DRAG WHAT WAS INSIDE THE PATIENT OUT WITH THE HEADLINER THROUGH THE SAME NON-BOSTON SCIENTIFIC MICROCATHETER. CASE WAS COMPLETED SUCCESSFULLY, AND NOTHING WAS LEFT IN PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20689347 ↗InjuryDec 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE FATHOM WIRE SNAPPED, FELL OFF IN THE ARTERY AND WAS REMOVED BY SNARING. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED FEMORAL ARTERY. A 200X25CM FATHOM -16 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FATHOM WIRE SNAPPED WHILE NAVIGATING INSIDE THE ARTERY. AS THE PHYSICIAN PULLED BACK ON WIRE, IT SNAPPED AND FELL OFF IN THE FEMORAL ARTERY. THE PIECE WAS SNARED OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 15941165 ↗
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- 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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