Direxion™ HI-FLO™ Transend™-18 System M001195940Recalls & reported problems

Boston Scientific Corporation · Pre-Loaded Torqueable Microcatheter · Class 2

Data updated Oct 18, 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 08714729839842), received between Sep 28, 2018 and May 14, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Fracture2
Detachment of Device or Device Component1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 14, 2026Fracture
IT WAS REPORTED THAT SHAFT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE LIVER. A NGMC/TRANSEND/027/BERN/1RO/130 DIREXION HI-FLO WAS SELECTED FOR USE. DURING THE PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FRACTURED AND UNUSED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25174324 ↗
MalfunctionMar 28, 2024Fracture; Fracture
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A DIREXION HI-FLO TRANSEND-18 SYSTEM CATHETER-INFUSION WAS SELECTED FOR USE. DURING THE PROCEDURE, AN IDC-18 COIL WAS SUCCESSFULLY DEPLOYED. A SECOND NON-BSC COIL WAS SELECTED. HOWEVER, DURING ADVANCEMENT, RESISTANCE WAS ENCOUNTERED. IT WAS UNABLE TO PULL BACK OR DEPLOY THE COIL. UPON REMOVAL, THE CATHETER OUTER TUBE WAS FOUND BROKEN. THE INNER LINING WAS INTACT, THE CATHETER WAS WITHDRAWN IN ONE PIECE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18997054 ↗
MalfunctionSep 28, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE OUTER SHAFT OF THE CATHETER WAS BROKEN AND DETACHED. A DIREXION HI-FLO TRANSEND-18 SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE MICROCATHETER WAS INTRODUCED THROUGH A NON-BSC DEVICE WITH THE TRANSEND 18 GUIDEWIRE, THE OUTER SHAFT OF THE MICROCATHETER BROKE AND DETACHED. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7918663 ↗

Device details

UDI-DI	`08714729839842`
Brand	Direxion™ HI-FLO™ Transend™-18 System
Model	M001195940
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	Mar 21, 2019

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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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