Notes

FDA's Most Dangerous Recalls 2022: Misplaced Feeding Tubes Ahead (Avanos Medical)
Based on FDA recalls The Avanos medical Cortrak2 feeding tube is among the top deadliest medical device.

https://bbs.pku.edu.cn/v2/jump-to.php?url=https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ While 2022 isn't over, FDA already has 50 medical devices on its recall list. These recalls have resulted in 36 deaths and 228 injuries. Avanos Medical ranks number one on the 2022 list of medical device malfunctions with 23 reported deaths from an improperly placed feeding tube.


These are the most dangerous medical device safety errors, in accordance with the FDA recall notification:

Avanos Medical Remands Cortrak*2 Enal Access System for Feeding Tubs
Inadvertently, removing nasogastric feeding tubes resulted in 60 injuries and 23 deaths.

The malfunction of this device is the main cause of death for all medical devices that were recalled by the FDA in 2022.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service because of injuries and deaths resulting from improper placement of nasogastric feeding tubes.


If a nasogastric, also known as a the nasoenteric tube is not correctly put in the wrong place, patients can be harmed by their vocal cords, lungs, or trachea. It could result in severe damage and even death. Avanos Medical notified that patients "...and hospitals should verify the positioning of N/NI tubes in accordance with hospital protocol. Fox News announced.

Avanos Medical Avanos Medical's recall announcement included the fatalities and injuries due to the misplacement the feeding tubes for the enteral system in the CORTRAK* 2 Enteral Access System as of 2015.

Baxter recalls SIGMA Spectrum Infusion Pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received 51 complaints regarding serious injuries as well as three deaths of patients which could be linked to this issue in the last five years.

Following numerous complaints about security alarms not working after numerous complaints of safety alarm malfunctions, the manufacturer of medical devices Baxter has announced a recall of this device. https://www.fcc.gov/fcc-bin/bye?https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Alarms on the pumps were not activating in the event of an upstream obstruction. These products could cause negative health effects that could result in death, according to the announcement.

Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been three injuries and 2 deaths associated by the use of this device.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube both utilized to help provide airway and laryngeal nerve systems during neck and head surgeries - were responsible for three injuries and two fatalities prior to Medtronic's recall. Medtronic isn't asking its clients to return or exchange the devices affected, but has sent out safety notices to ensure that the device's silicon cuff from blocking the patient's airway.


Patients may experience an oxygen deficiency, brain injury, or even death , if the tube is not properly ventilated.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has led to one injury and two deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor that connects to ventilators in line could stop patients at-home from getting enough oxygen. Patients at risk include people who breathe mucus, respiratory failure (pneumonia) as well as brain injuries (hypoxia), and the possibility of choking.


This is the list of deaths of humans in 2022 due to the malfunction of medical devices or their misuse.


https://list.ly/aycockvind614 Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) Occlusion-related events

Injuries: 51

Deaths: 3

Medtronic Recalls NIM CONTACT Reinforced EMG 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 Recalls 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 and V60 Plus Ventilators

Injuries: 4

Deaths: 1

Medtronic recalls HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic Recalls HeartWare HVAD System Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. feeding tube placement Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC is a Subsidiary of Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Covered Stent

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista1000 and 1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc Recalls SafeStar 55 Breathing System 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


Read More: https://www.fcc.gov/fcc-bin/bye?https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause