Michigan Critical Care Consultants, Inc. 4949Recalls & reported problems

Michigan Critical Care Consultants, Inc. · Soft Flow Extended Aortic Cannula 21FR 7MM VENTED · Class 2

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

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10854916006048), received between Jul 28, 2017 and Sep 9, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Material Deformation1
Use of Device Problem1

Patient problems

Foreign Body In Patient1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 9, 2025Material Deformation; Material Deformation
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A SOFT-FLOW EXTENDED ARTERIAL CANNULAE DEVICE, IT WAS REPORTED A KINK AT THE CANNULA'S TIP. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003479 ↗
MalfunctionJul 28, 2017Use of Device Problem; Use of Device Problem
INFORMATION RECEIVED BY MANUFACTURER (MC3) FROM DISTRIBUTOR ((B)(4)) ON MARCH 29, 2017. UPON ARTERIAL CANNULATION FOR A MITRAL VALVE REPAIR, SURGEON INSERTED SOFT FLOW CANNULA TIP INTO AORTA AND INADVERTENTLY PLACED THE PORTION OF THE CANNULA WITH THE SUTURE RING INTO THE AORTA. IT WAS REPORTED THAT THE SURGICAL PROCEDURE WAS MODIFIED TO SAFETY REMOVE THE CANNULA WITH THE SUTURE RING ATTACHED FROM THE AORTA. WHEN IT WAS TIME TO REMOVE THE CANNULA FROM THE PATIENT AT THE END OF THE CASE, THE SURGEON WAS CONCERNED THAT THE SUTURE RING COULD FALL OFF THE CANNULA BODY. AS A RESULT, HE DECIDED TO PUT THE PATIENT ON CIRCULATORY ARREST IN ORDER TO ENSURE SAFE REMOVAL OF THE DEVICE WITHOUT DETACHMENT OF THE SUTURE RING. IT WAS CONFIRMED THAT THE DEVICE WAS SAFELY REMOVED AND THE SUTURE RING REMAINED ATTACHED TO THE DEVICE. THERE WAS NO REPORTED ADVERSE EFFECT TO THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 6749819 ↗

Device details

UDI-DI	`10854916006048`
Brand	Michigan Critical Care Consultants, Inc.
Model	4949
Company	Michigan Critical Care Consultants, Inc.
Product code	DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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	Jun 19, 2024

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

A semi-rigid or rigid tube intended to be surgically inserted into an artery or vein to serve as a channel for the extracorporeal transport of oxygenated blood to a patient during cardiopulmonary bypass and/or extracorporeal membrane oxygenation; in some settings it may be referred to as an arterial 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 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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