PhenomTM 17 Catheter FG11150-0615-2XRecalls & reported problems

Micro Therapeutics, Inc. · CATHETER FG11150-0615-2X V06 US · Class 2

Data updated Oct 18, 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 00763000399672), received between Nov 25, 2025 and Nov 25, 2025 — classified as 1 malfunction.

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

Reports received per month

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

Most reported problems

Device problems

Physical Resistance/Sticking1
Retraction Problem1

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.

MalfunctionNov 25, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS UNDERGOING THE PROCEDURE TO TREAT A 6.1MM MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. VESSEL TORTUOSITY WAS MODERATE. DURING PREPARATION, THE INTRODUCER SHEATH WAS HELD VERTICALLY WHEN THE IMPLANT COIL WAS PULLED BACK INSIDE DURING HYDRATION. A CONTINUOUS FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. IT WAS CLARIFIED THAT WHEN RETRIEVING THE COIL, IT WAS STUCK IN THE MICROCATHETER SO THE SYSTEM WAS REMOVED TOGETHER. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT AND THE PATIENT WAS NOTED TO BE RECOVERING WITH NO PROBLEM. AFTER REMOVAL, IT WAS OBSERVED THE COIL WAS ELONGATED/STRETCHED AND THE FILAMENT WAS EXPOSED. THE CAUSE OF THE RESISTANCE WAS NOT DETERMINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23645020 ↗

Device details

UDI-DI	`00763000399672`
Brand	PhenomTM 17 Catheter
Model	FG11150-0615-2X
Company	Micro Therapeutics, Inc.
Product code	KRA · Catheter, continuous flush
Class	Class 2
FDA submission	K210230
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
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 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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