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

Micro Therapeutics, Inc. · CATHETER FG11150-0615-2S V06 US · 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 00763000399665), received between May 1, 2024 and Jun 11, 2025 — classified as 3 malfunctions.

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

Physical Resistance/Sticking2
Leak/Splash1
Material Integrity Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

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

MalfunctionJun 11, 2025Leak/Splash; Leak/Splash
MEDTRONIC RECEIVED A REPORT THAT PHENOM 017 LEAKED DURING PREPARATORY FLUSHING. IT WAS REPORTED THAT THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE MICROCATHETER WAS FLUSHED AS INDICATED IN THE IFU. A DEFECT WAS DETECTED DURING PREPARATION. WATER LEAKAGE OCCURRED WHEN FLUSHING WITH SALINE, SO THE MICROCATHETER WAS NOT USED. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22187570 ↗
MalfunctionJun 5, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
MEDTRONIC RECEIVED A REPORT THAT THE AXIUM COIL EXPERIENCED RESISTANCE IN THE PHENOM 17 CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR A CEREBRAL ANEURYSM. THE ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY, WHICH WAS 4MM IN DIAMETER. THE PATIENT'S BLOOD FLOW WAS NORMAL, AND THEIR VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE FIRST COIL WAS SUCCESSFULLY DEPLOYED AND DETACHED WITHOUT ANY ISSUES. HOWEVER, WHEN INSERTING THE SECOND COIL OF THE SAME PRODUCT, IT COULD NOT BE PUSHED OUT FROM THE CATHETER. ADDITIONALLY, IT BECAME IMPOSSIBLE TO RETRACT THE COIL, LEADING TO THE REMOVAL OF THE CATHETER ALONG WITH THE COIL. ACCESS TO THE ANEURYSM WAS REESTABLISHED USING A DIFFERENT PRODUCT, AND THE SUBSEQUENT EMBOLIZATION WITH COILS WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22150968 ↗
MalfunctionMay 1, 2024Material Integrity Problem; Physical Resistance/Sticking; Material Integrity Problem; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THE MICROWIRE WAS CHIKAI BLACK. THERE WAS NO DAMAGE TO THE INNER COATING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19226408 ↗

Device details

UDI-DI	`00763000399665`
Brand	PhenomTM 17 Catheter
Model	FG11150-0615-2S
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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