TRUSELECTRecalls & reported problems across all models

We found 7 models of TRUSELECT by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2020 and Apr 27, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUSELECT problems

TRUSELECT models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUSELECT™ M001394101300

  Catheter, continuous flush
  5 reports
• TRUSELECT™ M001394111550

  Catheter, continuous flush
  5 reports
• TRUSELECT™ M001394101750

  Catheter, continuous flush
  4 reports
• TRUSELECT™ M001394111300

  Catheter, continuous flush
  4 reports
• TRUSELECT™ M001394101550

  Catheter, continuous flush
  3 reports
• TRUSELECT™ M001394101050

  Catheter, continuous flush
  1 report
• TRUSELECT™ M001394111750

  Catheter, continuous flush
  1 report

Recent TRUSELECT adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 12, 2025Break; Break

  IT WAS REPORTED THAT A FRACTURE OCCURRED. A 155CM TRUSELECT WAS SELECTED FOR A TRANSARTERIAL CHEMOEMBOLIZATION (TACE) PROCEDURE IN THE LIVER. DURING INSERTION, THE CATHETER GOT FRACTURED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21584406 ↗
• MalfunctionDec 13, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE DISTAL MARKER WAS MISSING. A 175CM TRUSELECT WAS SELECTED FOR USE IN A PROSTATIC ARTERY EMBOLIZATION PROCEDURE. DURING REMOVAL FROM THE LOOP, THERE WAS NO DISTAL MARKER. THE PROCEDURE WAS COMPLETED WITH ANOTHER THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925658 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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