Hornet™ 10 H749393041900Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729887690), received between Aug 26, 2019 and Oct 3, 2022 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATE TO SEVERELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A 190CM, STRAIGHT-TIP HORNET 10 GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING, THE TIP OF THE GUIDEWIRE BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15530260 ↗MalfunctionAug 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE TIP DETACHMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN A SAPHENOUS VEIN GRAFT (SVG) IN THE NON-TORTUOUS AND MILDLY CALCIFIED VESSEL. A 190CM STRAIGHT-TIP HORNET 10 WAS SELECTED FOR USE. HOWEVER, DURING ANGIOGRAPHY, IT WAS NOTED THAT THE TIP WAS DAMAGED AND THE RADIOPAQUE SLEEVE WAS SEPARATED FROM THE TIP. THE WIRE WAS COMPLETELY REMOVED THROUGH THE NON-BSC MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8929871 ↗
Other WIRE, GUIDE, CATHETER devices
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- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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