TRUSELECT™ M001394101300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729976615), received between Jan 5, 2021 and Mar 19, 2026 — classified as 2 injuries, 3 malfunctions.

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

• MalfunctionMar 19, 2026Nonstandard Device; Difficult to Remove

  IT WAS REPORTED THAT THE DEVICE BECAME CRUSHED. THE 130 CM TRUSELECT CATHETER WAS USED FOR A PROSTATE ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE CATHETER WAS INSERTED AND PARTICLE DELIVERY WENT SMOOTHLY; THERE WERE NO ISSUES WITH TRACKING, GUIDEWIRE, OR PARTICLE DELIVERY. WHEN THE TRUSELECT CATHETER WAS REMOVED TO GAIN ACCESS TO THE OTHER SIDE, RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE CATHETER. THEN IT WAS NOTED THAT THE CATHETER WAS VISIBLY COLLAPSED/SQUISHED/CRUSHED TOWARD THE DISTAL END. THE GUIDEWIRE COULD NOT BE FED THROUGH BUT WAS BACKLOADED SUCCESSFULLY, ALLOWING DELIVERY TO THE OTHER SIDE WITH THIS CATHETER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640441 ↗
• MalfunctionFeb 17, 2026Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THIS 130CM TRUSELECT CATHETER WAS SELECTED FOR USE DURING A THERASPHERE Y90 PROCEDURE. DURING THE PROCEDURE, AS THE CATHETER WAS CONNECTED TO THE ADMINISTRATION SET TUBING, THE CATHETER BECAME KINKED. AN ATTEMPT WAS MADE TO UNROLL THE KINK IN THE TRUSELECT CATHETER AND THEN INJECT THE Y90 BEADS; HOWEVER, THE DRUG COULD NOT BE DELIVERED DUE TO THE KINK. THEREFORE, THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24366176 ↗
• InjuryOct 24, 2024Material Rupture; Material Deformation; Material Rupture; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. A TRU-SELECT WAS SELECTED FOR USE IN THE THERASPHERE PROCEDURE. WHEN THE PLUNGER ON THE THERASPHERE ADMINISTRATION SET WAS PRESSED TO DELIVER THE THERASPHERE MICROSPHERES, THERE WAS RESISTANCE ENCOUNTERED, CAUSING THE TRUSELECT TO BURST. AS A RESULT, THE THERASPHERE DOSE WAS MIS-ADMINISTERED TO THE GASTRODUODENAL ARTERY (GDA). WHEN THE TRUSELECT WAS REMOVED, THE PHYSICIAN OBSERVED A HOLE IN THE MICROCATHETER THAT WAS THOUGHT TO BE CAUSED FROM A KINK. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE. NO FURTHER DETAILS WERE PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC.

  Patient problems: Foreign Body Reaction

  MAUDE report 20526464 ↗
• MalfunctionAug 2, 2023Difficult to Flush; Material Rupture; Difficult to Flush; Material Rupture

  IT WAS REPORTED THAT THE CATHETER SHAFT RUPTURED. A TRUSELECT INFUSION CATHETER WAS SELECTED FOR USE TO TREAT HEPATOCELLULAR CARCINOMA (HCC) USING Y90. PRIOR TO INFUSING Y90, A CONTRAST RUN WAS PERFORMED. THE PHYSICIAN OBSERVED THAT THE CONTRAST APPEARED MORE PROXIMAL THAN EXPECTED. THE PHYSICIAN THEN OPTED TO EMBOLIZE A DISTAL VESSEL WITH GELFOAM PRIOR TO DELIVERING THE Y90 DOSE. HOWEVER, THE GELFOAM COULD NOT BE FLUSHED THROUGH THE CATHETER. THE CATHETER WAS REMOVED FROM THE PATIENT AND FLUSHED WITH SALINE. A SMALL HOLE AT THE DISTAL END OF THE CATHETER WAS OBSERVED. SALINE WAS SHOOTING OUT OF IT. A NEW DEVICE, SAME MODEL, WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17439773 ↗
• InjuryJan 5, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THE CATHETER BROKE. A 130CM TRUSELECT WAS SELECTED FOR AN EMBOLIZATION PROCEDURE WITHIN ABDOMINAL AREA VARICES. EMBOLIZATION WAS PERFORMED WITH A NON-BOSTON SCIENTIFIC COPOLYMER. THE COPOLYMER SEEMED TO HAVE SETTLED AROUND THE TRUSELECT CATHETER. DURING REMOVAL OF THE CATHETER, THE CATHETER STRETCHED AND BROKE. THE DETACHED FRAGMENT REMAINED WITHIN THE PATIENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE EMBOLIZATION PROCEDURE WAS COMPLETE. THE PATIENT WAS OK POST PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 11116847 ↗