Notes

FDA's most dangerous recalls of 2022 - Unplaced Feeding Tubes The most feared (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most hazardous medical devices as per FDA recalls.

While 2022 isn't over, FDA already has 50 medical devices on its recall list. The effect of the recalls so far is an unfortunate 36 deaths and more than 224 injuries. Avanos Medical is first on the list for 2022 regarding malfunctions of medical devices, and has 23 reported deaths due to faulty feeding tubes.


The following are the top four dangerous medical device safety errors, in accordance with the FDA recall notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
Incorrect placement of nasogastric feed tubes resulted in 60 injuries, and 23 fatalities.

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


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


Avanos Medical Patients are at risk of serious injury or even death if the nasogastric tub or nasoenteric one is incorrectly inserted. Avanos Medical Avanos Medical notified that users "...and hospitals must verify the placement of the N/NI tubes according to institution protocol. Fox News covered the story.

Avanos Medical reported in a recall notification that deaths and injuries were caused by the misplacement or misuse of the feed tubes to the stomach while using the CORTRAK*2 Ental Access System.

Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 cases of serious injury and three death of patients in the past five years.

feeding tube placement The medical device manufacturer Baxter Recalled this device after numerous reports of a security alarm malfunction. If there was an obstruction to the flow of the water the alarm was unable to trigger on the pumps. These substances can have adverse health effects that could cause death according to the announcement.

Avanos Medical Medtronic recalls EMG reinforced Endotracheal Tube
There have been 3 injuries and 2 deaths associated by the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to provide an airway and monitor laryngeal nerves during head or neck surgeries - were the source of three accidents and two deaths prior to Medtronic's recall. Although the company hasn't asked customers to return defective devices or exchange them, they have sent out security alerts to ensure the silicone cuff didn't restrict a patient's airway.


Patients can suffer from brain damage, oxygen deprivation or death if the tube doesn't ventilate well or block airways.

Baxter Healthcare Corporation Recalls Volara System
This device has been linked with one injury and two deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System because the in-line ventilator adaptor could hinder home-based patients from getting enough oxygen from their ventilators. The most vulnerable patients are breathing in mucus, respiratory failure (pneumonia) and brain injury (hypoxia) and the possibility of choking.


This is a list of the human life paid in 2022 for mishaps with medical devices or improper use:


Avanos Medical Remcalls Cortrak*2 Entry Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps that come with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) occlusion events

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced-EMG Endeotracheal Tube and the NIM Standards Reinforced-EMG Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Recalls Certain Medfusion 4000 and 3500 Syringe Infusion 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 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. Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC, Subsidiary to Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast that covered sten

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.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015