TRUSELECT™ M001394111550Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729976660), received between Nov 5, 2020 and Apr 27, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. THE RETURNED DEVICE EVALUATION REVEALED THE SHAFT WAS CRUSHED APPROXIMATELY 7.5CM FROM THE DISTAL TIP. A 155CM BERN TRUSELECT CATHETER WAS USED FOR A PROSTATE ARTERY EMBOLIZATION. ACCESSING A SMALL PENILE BRANCH TO COIL TOOK OVER AN HOUR, BUT ONE PUSHABLE, AND TWO EMBOLD COILS WERE SUCCESSFULLY DEPLOYED. THE MICROCATHETER PROLAPSED PROXIMALLY AND WAS REMOVED TO REGAIN ACCESS INTO THE PROSTATIC ARTERY. THEN IT WAS NOTED THAT A KINK WAS OBSERVED; THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009586 ↗
• MalfunctionJul 23, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICES WERE ENTRAPPED. A TRUSELECT MICROCATHETER AND A FATHOM 14 GUIDEWIRE WERE SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WOULD NOT TRACK THROUGH THE MICROCATHETER EASILY, AND THERE WAS DIFFICULTY REMOVING THE GUIDEWIRE FROM THE MICROCATHETER. BOTH DEVICES HAD TO BE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW TRUSELECT AND A NEW FATHOM. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579796 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. A 155CM TRUSELECT WAS SELECTED FOR USE. DURING PREPARATION, WHILE TRYING TO PULL THE STYLET OUT OF THE MICROCATHETER, THE TIP OF THE CATHETER CAME OFF WITH IT. THE PROCEDURE WAS COMPLETED WITH A NEW MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18191586 ↗
• MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A TIP BREAK OCCURRED. A 155CM TRUSELECT WAS SELECTED FOR USE. THE HOUSING HOOP WAS FLUSHED AND DURING REMOVAL OF THE CATHETER FROM THE HOOP, THE CATHETER TIP BROKE OFF. THE DEVICE NEVER ENTERED THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454680 ↗
• MalfunctionNov 5, 2020Leak/Splash; Leak/Splash

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16OCT2020. IT WAS REPORTED THAT A CATHETER LEAK OCCURRED. THE TARGET LESION WAS LOCATED IN SEGMENT 4 OF THE LIVER. A 155CM TRUSELECT WAS SELECTED FOR A PRE Y90 MAPPING OF COLORECTAL METASTASES. DURING LASER MAGNETIC RESONANCE (LMR), PRIOR TO ADMINISTERING THE MELANOMA-ASSOCIATED ANTIGEN (MAA), A COUPLE OF POWER INJECTIONS AT 700 PSI WERE PERFORMED. AFTER THE INJECTIONS, SALINE WAS PUSHED THROUGH THE CATHETER. A POOLING OF SALINE WAS NOTED AT APPROXIMATELY 3CM FROM THE HUB ALONG THE VESTIMID COATING OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A 2.4 MICROCATHETER. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A SLICE IN THE CATHETER SHAFT 23CM FROM THE HUB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10791373 ↗