Notes

The FDA's most deadly recalls for 2022 - Unplaced Feeding Tubes Inspiring (Avanos Medical)
According to FDA recalls, the Avanos Medical Cortrak2 feeding tube is among the highest-risk medical device.

Cortrak 2 eternal access system Even though 2022 isn't finished even though 2022 isn't over yet, the FDA has already created the following list of recalls of medical devices. The impact of the recalls so far is a sad 36 deaths and 228 injuries. Avanos Medical is first on the 2022 list for malfunctions with medical devices, with 23 deaths attributed to feeding tubes that were not properly placed.


Avanos Medical feeding tube These are the top four dangerous medical device malfunctions according to the FDA recall notice.

Cortrak 2 eternal access system Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
The improper placement of nasogastric feeding tubes caused the deaths of 23 and injuries to 60.

This is the most common cause of death in recalled devices.


Avanos Medical feeding tube Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due to death and injuries resulting from improper placement of nasogastric feeding tubes.


Patients are at risk of serious injury or even death, if a nasal tube or nasoenteric tub is improperly placed. Avanos Medical issued a announcement to patients requesting that they confirm the placements of the NG/NI tubing according to institutional protocol. Fox news covered the story.

Avanos Medical's recall communications reported the injuries and deaths related to the misplacement of the enteral feeding tubes during the use of the CORTRAK* 2 Enteral Access System as of 2015.

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received reports concerning serious injuries and three deaths of patients that could be connected to this issue over the last five years.

Avanos Medical Following numerous complaints of safety alarm malfunctions and malfunctions in safety alarms, the medical device maker Baxter has announced a recall of the device. In the event of an obstruction to the flow of the water the alarm was unable to be activated on the pumps. Warnings were made that these products could result in adverse health effects and even death.

https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ Medtronic Recalls NIM Contact Reinforced EMG Endotracheal Tube
There have been 3 accidents and 2 deaths attributed by the use of this device.

Cortrak 2 eternal access system The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube - which are utilized to create an airway and monitor laryngeal nerves undergoing head and neck surgeries - were the source of three injuries and two deaths prior to Medtronic's recall. Avanos Medical While Medtronic hasn't asked customers to return damaged devices, it has released safety announcements in an effort to stop the silicone cuff from blocking a patient’s airway.


Patients could suffer from the deprivation of oxygen, brain injuries or even die if the tube is not ventilated appropriately.

Baxter Healthcare Corporation Recalls Volara System
The use of this device led to 1 injury, 2 deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the in-line ventilator adaptor could hinder home-based patients in getting enough oxygen from their ventilators. https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ The risk for patients affected include choking on mucus or other airway mucus, lung infection (pneumonia) which prevents oxygen from getting to the blood (respiratory failure), brain injury caused by lack of oxygenation to the brain (hypoxia) and even death.


This is a list of human life paid in 2022 for medical device malfunction or misuse:


Avanos Medical Remcalls Cortrak*2 Entry Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps (Version 8) and Spectrum IQ Infusion Systems (Version 9) occlusions

Injuries: 51

Deaths: 3

Medtronic Recalls NIM CONTACT Reinforced Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Remands Certain Medfusion 3500 and 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic recalls HeartWare HVAD System Batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump Kit

Injuries: 2

Deaths: 1

Medtronic recalls batteries for HeartWare HVAD system.

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC is a subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stents Covered

Injuries: 9

Deaths: 0

Vyaire Medical recalls bellavista 1000 Series and 1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc recalls SafeStar 55 Breathing Systems Filters

Injuries: 1

Deaths: 0

Abbott Medical Recalls Dragonfly OpStar Imaging Catheter

Injuries: 1

Deaths: 0

SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests

Injuries: 1

Deaths: 0


Homepage: https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/