Direxion™ M001195270Recalls & reported problems

Boston Scientific Corporation · Torqueable Microcatheter · Class 2

All models of Direxion (14)

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 08714729839385), received between Jan 15, 2019 and Jul 25, 2022 — classified as 3 malfunctions.

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

Most reported problems

Device problems

Leak/Splash1
Material Deformation1
Material Integrity Problem1

Patient problems

No Consequences Or Impact To Patient2
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionJul 25, 2022Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A LEAK FROM THE DISTAL TIP OCCURRED. A DIREXION INFUSION CATHETER AND NON-BSC LIQUID EMBOLIC SYSTEM WERE SELECTED FOR AN EMBOLIZATION PROCEDURE TO TREAT AN ENDOLEAK IIB. DURING EMBOLIZATION, A SHAFT LEAK WAS OBSERVED AT THE DISTAL END. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15098444 ↗
MalfunctionDec 4, 2020Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE CATHETER COATING DETACHED. A 130CM DIREXION CATHETER WAS SELECTED FOR AN EMBOLIZATION PROCEDURE IN THE CHEEK HEMANGIOMA. DURING THE PROCEDURE, THE CATHETER COATING DETACHED. THE CATHETER WAS COMPLETELY REMOVED BY PULLING OUT. A NON-BOSTON SCIENTIFIC CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10943212 ↗
MalfunctionJan 15, 2019Material Deformation; Material Deformation
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-DEC-2018. IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE TARGET LESION WAS LOCATED IN THE TORTUOUS LEFT INTERNAL ILIAC ARTERY. A 130CM DIREXION WAS SELECTED FOR USE. DURING PROCEDURE, THE .035 GLIDE CATHETER WAS ADVANCED INTO THE LESION AND THEN THE DIREXION CATHETER WAS INSERTED THROUGH THE GLIDE CATHETER WITH THE FATHOM WIRE. SUBSEQUENTLY, THE DIREXION CATHETER WAS KINKED DURING MANIPULATION AND NAVIGATION THROUGH THE TORTUOUS ANATOMY. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DEVICE FRACTURE AT 58CM FROM THE HUB.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8246942 ↗

Device details

UDI-DI	`08714729839385`
Brand	Direxion™
Model	M001195270
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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