TRUSELECT™ M001394101050Recalls & reported problems
Boston Scientific Corporation · Microcatheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729976608), received between Feb 26, 2024 and Feb 26, 2024 — classified as 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE MICROCATHETER SEPARATED. A STRAIGHT TIP 105CM TRUSELECT MICROCATHETER WAS SELECTED FOR USE IN AN INTERVENTIONAL RADIOLOGY CASE. DURING THE PROCEDURE, THE MICROCATHETER SEPARATED WHILE LOADING OVER THE FATHOM GUIDEWIRE. SEPARATION OCCURRED AT THE TRANSITION FROM THE FLEXIBLE PORTION OF THE MICROCATHETER TO THE MORE SOLID BODY OF THE MICROCATHETER. THE DEVICE WAS REMOVED, AND ANOTHER TRUSELECT OF THE SAME SIZE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18778587 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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