TRUSELECT™ M001394101750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729976639), received between Sep 7, 2021 and Nov 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THERE WAS A HOLE PRESENT IN THE MICROCATHETER. A TRUSELECT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS OBSERVED BY THE PHYSICIAN THAT THERE WAS A HOLE IN THE CATHETER LUMEN. NO FURTHER INFORMATION WAS PROVIDED REGARDING THE PROCEDURE OR PATIENT STATUS, DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600732 ↗
• MalfunctionMar 6, 2024Fracture; Difficult to Remove; Failure to Advance; Fracture; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT FRACTURES OCCURRED. A 175CM TRUSELECT AND A 014X200CM FATHOM GUIDEWIRE WERE SELECTED FOR USE IN A Y90 PROCEDURE TO TREAT HEPATOCELLULAR CARCINOMA (HCC). THE CATHETER WAS ADVANCED WITH THE GUIDEWIRE THROUGH THE TORTUOUS ANATOMY. THE GUIDEWIRE WAS REMOVED TO TAKE AN ANGIOGRAM. THE GUIDEWIRE WAS ADVANCED AGAIN IN ATTEMPT TO ADVANCE THE CATHETER A LITTLE FURTHER IN THE VESSEL WHERE TREATMENT WAS PLANNED; HOWEVER, ADVANCEMENT DIFFICULTY OCCURRED DUE TO THE "CURLY Q" IN THE VESSEL. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS, THE FATHOM AND TRUSELECT WERE REMOVED WITH RESISTANCE. MULTIPLE FRACTURES WERE NOTED ON THE TRUSELECT. A NEW TRUSELECT AND FATHOM WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852310 ↗
• MalfunctionNov 30, 2021Material Perforation; Material Deformation; Material Perforation; Material Deformation

  IT WAS REPORTED THE GUIDEWIRE PUNCTURED THROUGH THE CATHETER AND THE PROCEDURE WAS CANCELLED. A 175CM TRUSELECT CATHETER WAS SELECTED FOR A PROSTATE ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE IT WAS NOTED THAT THE CATHETER WAS KINKED AND THE WIRE WAS GOING THROUGH THE SIDEWALL OF THE CATHETER AT THE KINK. THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER BACK AND THEN REMOVED THE CATHETER AND NOTED THE KINK. THEY DID NOT HAVE ANOTHER CATHETER TO COMPLETE THE PROCEDURE, SO THE CASE WAS CANCELLED AND RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12902605 ↗
• MalfunctionSep 7, 2021Difficult to Remove; Stretched; Difficult to Remove; Stretched

  IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO REMOVE. A TRUSELECT 175CM STRAIGHT MICROCATHETER WAS SELECTED FOR USE IN A PROSTATE ARTERY EMBOLIZATION PROCEDURE. UPON REMOVAL FROM THE PATIENT, IT WAS REPORTED THAT THERE WAS DIFFICULTY REMOVING THE DEVICE, CAUSING THE DEVICE TO STRETCH NEAR THE HUB AND BECOME UNUSABLE. A NEW MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12434653 ↗