Notes

The most deadly FDA Recalls 2022. Misplaced Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, Avanos Medical Cortrak2 is the most hazardous medical device.

While 2022 is not yet completed, FDA already has 50 medical devices listed on its recall list. The effect of these recalls thus far is an unfortunate 36 deaths and more than 224 injuries. Avanos Medical ranks number one on the 2022 list of medical device malfunctions with 23 deaths related to the wrong placement of the feeding tube.


The following are the top four risky medical device mistakes according to the FDA recall notification:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently removing nasogastric feeding tube tubes resulted in 60 injuries and 23 deaths.

The device's malfunction is the main cause of death for all recalls of medical devices by the FDA in 2022.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injury and death in patients who received nasogastric or nasoenteric feeding tubes that were placed incorrectly.


If a nasogastric or nasal, or nasoenteric, tube has been incorrectly placed, patients may be injured to their vocal cords, lungs, or the trachea. Avanos Medical This can cause serious damage and even death. Cortrak 2 eternal access system Avanos Medical issued a notification to patients requesting that they verify the location of the NG/NI tubes in accordance with the institution's procedure. Fox news covered the story.

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

Baxter recalls SIGMA Spectrum Infusion pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received reports regarding serious injuries as well as three cases of patient deaths that could be related to this concern over the past five years.

The medical device maker Baxter recalled this device following numerous reports of a safety alarm malfunction. The alarms on the pumps were not triggering in the case of upstream occlusion events. These products can cause adverse health consequences that could lead to death according to the announcement.

https://dailyhornet.com/2022/feeding-tube-placement-devices-recalled-after-23-deaths-reported/ Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube with EMG
The device's use led to 3 injuries, and 2 deaths.

https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/ The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube that are utilized to create an airway and monitor laryngeal nerves during head and neck surgery - have been the source of three injuries and two deaths ahead of Medtronic's recall. While the company does not ask customers to return the defective devices or exchange the devices, they did send out security alerts to ensure the silicone cuff didn't impair a patient's airway.


Patients can suffer from cerebral damage, oxygen deprivation or death when the tube isn't ventilated well or blocks the airway.

Baxter Healthcare Corporation Recalls Volara System
The application of this device led to 2 injuries, and 1 deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the inline ventilator adaptor could hinder home-based patients not getting enough oxygen through their ventilators. https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Patients at risk include breathing in mucus, respiratory failure (pneumonia) and brain injury (hypoxia) and choking.


This is the list of human deaths in 2022 due malfunctioning medical devices or improper use.


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) obstructions

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced-EMG Endotracheal 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 3500 and 4000 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 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 is a subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls ICast, a Stent that is covered by the iCa

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista 1000 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

Cortrak 2 eternal access system
My Website: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement/