MEDLINE ECVC6215Recalls & reported problems

Medline Industries, Inc. · CVC BUNDLE, INTROFLEX 1L 9FR 7.5' · Class 2

Data updated Oct 16, 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 10653160342861), received between Dec 6, 2024 and Dec 6, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (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 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Connection Problem1

Patient problems

Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

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

InjuryDec 6, 2024Connection Problem; Connection Problem
RIGHT IJ CORDIS TUBE DISCONNECTED FROM WHITE INTRODUCER.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20872056 ↗

Device details

UDI-DI	`10653160342861`
Brand	MEDLINE
Model	ECVC6215
Company	Medline Industries, Inc.
Product code	OES · Cardiac catheterization kit
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	Feb 5, 2021

Device type (GMDN): Central venous catheterization kit, short-term

A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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All Cardiac catheterization kit devices →

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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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