TRUSELECT™ M001394111750Recalls & reported problems

Boston Scientific Corporation · Microcatheter · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729976677), received between Dec 13, 2024 and Dec 13, 2024 — classified as 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Separation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

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 ↗

Device details

UDI-DI	`08714729976677`
Brand	TRUSELECT™
Model	M001394111750
Company	Boston Scientific Corporation
Product code	KRA · Catheter, continuous flush
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Aug 25, 2020

Device type (GMDN): Vascular microcatheter

A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.