FATHOM™ -16 M001509210Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729961123), received between May 13, 2019 and May 2, 2025 — classified as 3 injuries.
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. 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 Component2
- Material Integrity Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 2, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED VIA ATTACHED VOLUNTARY MEDWATCH REPORT # (B)(4). THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE IN A VISCERAL ANGIOGRAM. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP OF THE WIRE INADVERTENTLY SHEARED OFF INTO THE BRANCH OF SUPERIOR MESENTERIC ARTERY. THE TIP OF THE WIRE WAS COMPLETELY REMOVED WITH A GOOSENECK SNARE. A REPEAT ANGIOGRAM WAS PERFORMED AND CONFIRMED THE RESOLUTION OF HEMORRHAGE. PATIENT WAS STABLE AND SCHEDULED FOR A COLONOSCOPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21954315 ↗InjuryApr 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE GUIDEWIRE WAS FRACTURED AND REMAINED INSIDE THE PATIENT. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE TORTUOUS AND NON-CALCIFIED VESSEL IN THE ABDOMEN. A 200X25CM ANGLED FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE IN AN ENDOLEAK PROCEDURE. DURING THE PROCEDURE, THE DEVICE WAS USED TO NAVIGATE THE VESSEL. AFTER MULTIPLE PASSES, IT WAS NOTED THAT THE GUIDEWIRE FRACTURED AT THE ILEOLUMBUS BRANCH. AS THE FRACTURE OCCURRED IN A VESSEL THAT WAS PLANNED TO BE EMBOLIZED, THE FRACTURED PORTION WAS LEFT INSIDE THE VESSEL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: Foreign Body In Patient
MAUDE report 14229294 ↗InjuryMay 13, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE BROKE AND REMAINED INSIDE THE PATIENT. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND SEVERELY CALCIFIED LIVER. A 200X25CM ANGLED FATHOM -16 GUIDEWIRE WAS SELECTED FOR USE IN AN EMBOLISATION PROCEDURE TO STOP BLEEDING. DURING PROCEDURE, IT WAS NOTED THAT THE TIP OF THE WIRE CAME OFF. STRONG ATTEMPT WERE MADE TO REMOVE THE FRACTURED TIP WITHOUT SUCCESS. HOWEVER, THE REST OF THE WIRE WAS RETRIEVED FROM THE PATIENT'S BODY. THE BLEEDING THEN SEEMED TO HAVE STOPPED, THUS THE PROCEDURE WAS ABANDONED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8604884 ↗
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- 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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