TRUSELECT™ M001394101550Recalls & reported problems
Boston Scientific Corporation · Microcatheter · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729976622), received between Sep 23, 2022 and Mar 12, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Difficult to Open or Remove Packaging Material1
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 18, 2023Fracture; Fracture
IT WAS REPORTED THAT THE DEVICE FRACTURED. THIS 155CM TRUSELECT INFUSION CATHETER WAS BEING PREPARED FOR USE AND WAS FLUSHED NORMALLY. HOWEVER, WHEN BEING REMOVED FROM THE HOOP IT SNAPPED. THE CATHETER WAS NOT USED IN THE PATIENT. ANOTHER TRUSELECT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17768706 ↗MalfunctionSep 23, 2022Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material
IT WAS REPORTED THAT THE CATHETER BROKE. A 155CM TRUSELECT WAS SELECTED FOR USE. DURING PREPARATION, THE CATHETER WAS UNABLE TO BE PULLED OUT FROM THE PLASTIC SHELL AND THE CATHETER BROKE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15469389 ↗
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- Renegade™ HI-FLO™ Kit M001183020Boston Scientific Corporation · Catheter, continuous flush109 reports
- MarksmanTM FA-55150-1030Micro Therapeutics, Inc. · Catheter, continuous flush109 reports
- EkoSonic® 6779-002Boston Scientific Corporation · Catheter, Continuous Flush1 recall4 deaths56 reports
- Chameleon CH08-40-75USMozarc Medical US LLC · Catheter, continuous flush2 recalls4 reports
- RebarTM 105-5081-153Micro Therapeutics, Inc. · Catheter, continuous flush2 deaths102 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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