MC2® 91240Recalls & reported problems

Medtronic, Inc. · CANNULA 91240 MC2 VEN 32/40FR 10PK 17L · Class 2

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 20613994887317), received between Sep 3, 2025 and Sep 3, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Crack1

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.

MalfunctionSep 3, 2025Crack; Crack
IT WAS REPORTED THAT DURING USE OF THE MC2 TWO STAGE VENOUS CANNULA IN THE MIDDLE OF A CASE, A CRACK WAS OBSERVED IN THE MIDDLE OF THE CANNULA. THE INNER LUMEN REMAINED INTACT AND THERE WAS NO BLOOD LOSS DUE TO THE CRACK. THERE WAS NO DAMAGE NOTED AT THE LOCATION OF THE SUTURES. THE CANNULA WAS CONTINUED TO BE USED THROUGHOUT THE CASE AND WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22950876 ↗

Device details

UDI-DI	`20613994887317`
Brand	MC2®
Model	91240
Company	Medtronic, Inc.
Product code	DWF · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Class	Class 2
FDA submission	K140165, K251258, K915268
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 10, 2025

Device type (GMDN): Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

A semi-rigid or rigid tube intended to be surgically inserted into the right atrium or large vein to serve as a channel for the extracorporeal transport of deoxygenated blood from a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as a venous cannula. It is typically inserted using a compatible trocar blade which may be included. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.