Samurai™ H749393023000Recalls & reported problems
Boston Scientific Corporation · Guidewire · Class 2
All models of Samurai (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729887843), received between Feb 10, 2020 and May 15, 2020 — classified as 1 injury, 1 malfunction.
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.
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Difficult to Remove1
Patient problems
- Chest Pain1
- Device Embedded In Tissue or Plaque1
- 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.
InjuryMay 15, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT TIP DETACHMENT OCCURRED AND REMAINED IN THE PATIENT. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND HIGHLY CALCIFIED DISTAL LEFT ANTERIOR DESCENDING ARTERY. A 300CM, STRAIGHT-TIP SAMURAI GUIDEWIRE WAS USED AND 1 INCH DETACHED IN THE DISTAL LAD. MULTIPLE BALLOONS WERE USED IN THIS CASE AND STENTING WAS NOT SUCCESSFUL. THE PATIENT WENT TO SURGERY WITH CHEST PAINS. SURGERY WAS PERFORMED BUT THE DETACHED TIP COULD NOT BE RECOVERED. NO FURTHER COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.
Patient problems: Chest Pain; Device Embedded In Tissue or Plaque
MAUDE report 10061563 ↗MalfunctionFeb 10, 2020Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DIFFICULTY REMOVAL OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT AND 300CM STRAIGHT TIP SAMURAI GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, THE STENT GOT DAMAGED BY ATTEMPTING TO PULL OFF FROM THE WIRE, IT GOT STUCK. THE PORTION OF THE WIRE THAT GOT STUCK WAS CUT OFF. THE PROCEDURE WAS COMPLETED WITH A NEW SYNERGY STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS GREAT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9687319 ↗
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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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