TRUSELECT™ M001394111300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729976653), received between Dec 11, 2023 and Apr 20, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (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.

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.

• MalfunctionApr 20, 2026Fracture

  IT WAS REPORTED THAT THE TRUSELECT FRACTURED INTERNALLY. A TRUSELECT? WAS SELECTED FOR USE TO TREAT A BLEED IN A BRANCH OF THE INTERNAL ARTERY. THE TRUSELECT AND HOOP WERE FLUSHED PRIOR TO USE. THE PHYSICIAN PLACED A NON-BOSON SCIENTIFIC (BSC) GUIDE CATHETER, THE TRUSELECT, A TRANSEND-14 GUIDEWIRE, AND AN 010 NON-BSC GUIDEWIRE. THE PHYSICIAN ATTEMPTED TO ADVANCE THE WIRE AND NOTICED THE TIP OF THE GUIDE CATHETER WAS JUMPING AND TRYING TO STRAIGHTEN. THE PHYSICIAN ELECTED TO REMOVE THE ENTIRE MICROSYSTEM AND NOTICED THAT THE NON-BSC WIRE WAS ALL BENT UP AND THAT THE TRUSELECT HAD FRACTURED. NO PORTION OF THE DEVICE WAS LEFT WITHIN THE PATIENT, AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE TRUSELECT WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24931066 ↗
• MalfunctionSep 16, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT WHEN THE MICROCATHETER ENTERED THE BISECTION, IT COULD NOT BE ADVANCED. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS VESSEL LEADING TO RENAL HAMARTOMA. A SELECTIVE MC SINGLE BERN 130CM TRUSELECT INFUSION CATHETER WAS SELECTED TO TREAT THE RENAL HAMARTOMA. WHEN THE CATHETER ENTERED THE BISECTION, HOWEVER, THE CATHETER BECAME ASTRINGENT AND COULD NOT BE ADVANCED. AFTER WITHDRAWAL, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED SHAFT SEPARATION LOCATED APPROXIMATELY 53CM FROM THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23066195 ↗
• MalfunctionAug 15, 2025Break; Break

  IT WAS REPORTED THAT THE MICROCATHETER BROKE. A SELECTIVE MC SINGLE BERN 130CM TRUSELECT WAS SELECTED FOR PROSTATE ARTERY EMBOLIZATION TO TREAT BENIGN PROSTATIC HYPERPLASIA. DURING REMOVAL, IT WAS OBSERVED THAT THE CATHETER BROKE. THE ORIGINAL DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE PRIOR TO THE BREAK. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816664 ↗
• MalfunctionDec 11, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE RADIOPAQUE MARKER WAS MISSING. A 130CM TRUSELECT MICROCATHETER WAS SELECTED FOR USE IN A Y90 MAPPING PROCEDURE. DURING INSERTION IT WAS OBSERVED THAT THE MICROCATHETER DID NOT HAVE A RADIOPAQUE MARKER. A NEW MICROCATHETER WAS OPENED, WHICH DID HAVE THE RADIOPAQUE MARKER. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18302622 ↗