Echelon 190-5091-150Recalls & reported problems

Micro Therapeutics, Inc. · 10 Micro Catheter;90 Degree Tip Shape · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 00836462002357), received between May 15, 2026 and May 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K093750); they may or may not involve this specific model.

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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Physical Resistance/Sticking1

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.

MalfunctionMay 15, 2026Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT A COIL ENCOUNTERED RESISTANCE AT THE HUB OF A ECHELON CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A COIL EMBOLIZATION WITH AN ANTERIOR CEREBRAL ARTERY (ACA) ACCESS VESSEL OF 2.5MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE COIL GOT CAUGHT AT THE HUB DURING INSERTION WHICH OCCURRED TWICE. THE HYDRO SOFT, AND TARGET TETRA SIZE WAS UNKNOWN, SO IT WAS DETERMINED TO BE A PROBLEM WITH THE CATHETER. THERE WAS RESISTANCE AT THE HUB OF THE CATHETER. THE SHEATH TIP WAS FIRMLY POSITIONED AT THE HUB. THE CATHETER WAS COLLECTED, CHANGED TO SL10 THEN THE PROCEDURE CONTINUED. DEVICES WERE PREPARED AS INDICATED IN THE PACKAGE INSERT. NO PATIENT COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED. THE CONCOMITANT COIL WAS NOT A MEDTRONIC PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186471 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093750. One submission often covers many models, so check the product and lot details in each record.

Z-1556-2022 · Jun 30, 2022 · Open, Classified
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Z-1557-2022 · Jun 30, 2022 · Open, Classified
Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only

Device details

UDI-DI	`00836462002357`
Brand	Echelon
Model	190-5091-150
Company	Micro Therapeutics, Inc.
Product code	KRA · Catheter, continuous flush
Class	Class 2
FDA submission	K093750
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	Dec 22, 2021

Device type (GMDN): Vascular guide-catheter, single-use

A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. 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 13, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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