Samurai™ RC H749393061900Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729887737), received between Oct 25, 2019 and Jun 5, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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
- Material Integrity Problem2
- Difficult to Remove1
- Fracture1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 5, 2026Nonstandard Device; Material Integrity Problem
IT WAS REPORTED THAT A COATING ISSUE OCCURRED. A SAMURAI RC GUIDEWIRE WAS SELECTED FOR TREATMENT OF THE TARGET LESION. DURING THE PROCEDURE, THE GUIDEWIRE COATING BEGAN TO COME OFF. THE DEVICE WAS REMOVED, AND ANOTHER GUIDEWIRE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25414279 ↗InjuryJun 4, 2021Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IF REPORTED VIA USER FACILITY OR VOLUNTARY MEDWATCH # (B)(4) THAT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. DURING A PERCUTANEOUS CORONARY INTERVENTION INVOLVING A 190CM, STRAIGHT-TIP SAMURAI RC GUIDEWIRE, RESISTANCE WAS ENCOUNTERED DURING AN ATTEMPT TO REMOVE THE DEVICE. THE PHYSICIAN HAD TO THREAD ANOTHER SHEATH OVER THE TOP OF THE GUIDEWIRE TO REMOVE IT SAFETY FROM THE PATIENT. UPON INSPECTION, THE TIP OF THE DEVICE WAS FOUND FRAYED AND POSSIBLY UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11940790 ↗MalfunctionOct 25, 2019Fracture; Fracture
IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 190CM, STRAIGHT-TIP SAMURAI RC GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE DEVICE GOT BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED THAT THE PART OF THE DEVICE THAT WAS DAMAGED IS THE DISTAL TIP, WHERE THE INNER COIL TECHNOLOGY (ICT) IS LOCATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9239678 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page