STRAIGHT FEMORAL MCF64Recalls & reported problems

Medical Components, Inc. · 14GA X 13.3CM (5 1/4") STRAIGHT FEMORAL CATHETER · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884908026757), received between Nov 20, 2018 and Nov 20, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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

Break1

Patient problems

Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 20, 2018Break; Break
THIS REPORT INVOLVES A GENTLEMAN WHO HAD A STRAIGHT FEMORAL CATHETER INSERTED FOR VASCULAR ACCESS. THE FEMORAL VEIN WAS CANNULATED AND A GUIDE WIRE WAS PASSED WITH EASE. THE CATHETER WAS THREADED OVER THE GUIDE WIRE. AS THE GUIDE WIRE WAS REMOVED, THE THERMOPLASTIC LEUR LOCK WHICH IS THE EXTERNAL ELEMENT OF THE CATHETER GOT DETACHED FROM THE CATHETER SHEATH LEAVING THE CATHETER BURIED INSIDE THE BODY. IMAGING WITH AN XRAY AND ULTRASOUND SHOWED THE POSITION OF THE CATHETER IN THE FEMORAL VEIN. THIS GENTLEMAN REQUIRED A DEEP EXPLORATION TO BE DONE BY A VASCULAR SURGEON FOR RETRIEVAL OF THE CATHETER.
Patient problems: Foreign Body In Patient
MAUDE report 8090846 ↗

Device details

UDI-DI	`00884908026757`
Brand	STRAIGHT FEMORAL
Model	MCF64
Company	Medical Components, Inc.
Product code	LFK · CATHETER, FEMORAL
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	Not in Commercial Distribution
Record updated	Dec 11, 2019

Device type (GMDN): Femoral artery/vein access catheter

A thin, flexible tube intended to be surgically inserted into the femoral artery or the femoral vein to provide an alternative access to a patient's vasculature, typically when other access routes are not viable or are exhausted. It may be used for continuous arteriovenous (AV) haemofiltration, the delivery of chemotherapeutic agents, or for other chronic applications to avoid repetitive injections. This is a single-use device.

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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