Notes

The FDA's most dangerous recalls of 2022 Incorrect Feeding Tubes The most feared (Avanos Medical)
As per FDA recalls, Avanos ' Medical Cortrak2 is the most dangerous medical device.

Even though 2022 isn't over The FDA has already prepared an inventory of 50 recalls of medical devices. Avanos Medical feeding tube This recall has caused 36 deaths and 228 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions , with 23 deaths reported due to misplaced feeding tubes.


They are the deadliest medical device failures as per the FDA medical device recall notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
The improper placement of feeding tubes caused more than 23 deaths and 60 injuries.

This is the leading reason for death in recalled devices.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of deaths and injuries for patients who received Nasogastric and nasoenteric tubes that were improperly placed.


Patients could be seriously injured or even death if the nasogastric tube or nasoenteric tub has been incorrectly inserted. As a precaution, Avanos Medical sent notice to providers asking either the user or the facility "...confirm the placement of the NG/NI tubes per institutional procedure" Fox news reported.

Avanos Medical reported in a recall announcement that deaths and injuries were caused by the improper placement or use of food tube for enteral use while employing the CORTRAK*2 Ental Access Systems.

Baxter recalls SIGMA Spectrum Infusion pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter received 51 complaints of serious injuries and three reports of patients' deaths over the last five years.

Baxter, a producer of medical devices recalls the device due to reports of a malfunctioning safety alarm. Alarms on the pumps were not activating in the event of occlusions in the upstream. The warnings were issued that these products could have adverse health consequences and may even lead to death.

Medtronic recalls NIMCACT reinforced Endotracheal Tube EMG
The device's use led to 3 injuries, and 2 deaths.

Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube that are used to track laryngeal and head nerves. While the company does not ask customers to return the defective devices or to replace the devices, they did send out security alerts to ensure the silicone cuff didn't restrict a patient's airway.


Avanos Medical If the tube does not adequately ventilate or block the airway, patients might be afflicted with oxygen deprivation as well as brain damage, and even death.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has 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 in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. Patients who are affected are choking on mucus, or other airway mucus, lung infections (pneumonia) that blocks oxygen from getting to the bloodstream (respiratory failure) and brain injuries caused by lack of oxygen to the brain (hypoxia), and death.


This is a list containing human lives that were lost because of the misuse of medical devices or their malfunction in 2022.


https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Avanos Medical feeding tube Avanos Medical feeding tube Avanos Medical Recalls Cortrak*2 Ental 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) the occlusion event

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 & 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 the 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. Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast with a sten cover.

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 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

https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/
Read More: https://avanos.com/investor-news/response-to-inquiries-about-the-avanos-cortrak-2-voluntary-field-correction/