Notes

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

Cortrak 2 eternal access system Even though 2022 isn't yet over but the FDA has already put together an inventory of 50 recalls of medical devices. The recalls have resulted in 36 deaths and 224 injuries. Avanos Medical is first on the list of 2022 malfunctions of medical devices, and has 23 reported deaths due to faulty feeding tubes.


Avanos Medical feeding tube These are the four most risky medical device mistakes in accordance with the FDA recall notification:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
Inadvertently taking out nasogastric tube feeding tubes has resulted in 60 injuries as well as 23 deaths.

This is the most frequent reason for death in recalls of devices.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injury and death among patients who had Nasogastric or Nasoenteric feeding tubes that were incorrectly placed.


Patients could suffer serious injury or even death if a nasogastric tub or nasoenteric one is incorrectly inserted. Avanos Medical notified that patients "...as well as hospitals should confirm the placement of the N/NI tubes in accordance with institutional guidelines. feeding tube placement Fox News covered the story.

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

Baxter recalls SIGMA Spectrum Infusion Systems that include Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter received 51 reports of serious injury and three reports on patient deaths in the past five years.

Following numerous complaints of security alarms not working, the medical device maker Baxter has recalled the device. If there was an obstruction upstream the alarm was unable to activate on the pumps. The announcement warned users that using the affected products could cause negative health effects, such as death.

Medtronic Recalls EMG Reinforced Endotracheal Tube
The device has been associated with three injuries and two deaths.

Three injuries and two deaths resulted from the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube both of which are used to monitor laryngeal and head nerves. https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A Avanos Medical The company doesn't want customers to return or swap the devices affected, but has they have issued safety announcements to keep the device's cuff from blocking the patient's airway.


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

Baxter Healthcare Corporation Recalls Volara System
There was one incident of injury and 2 deaths associated with the use of this device.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor connected to ventilators may prevent home-use patients getting enough oxygen. The potential risks for affected patients are choking on mucus, or other airway mucus, lung infections (pneumonia) which prevents oxygen from getting to the blood (respiratory failure), brain injury caused by a lack in oxygen to the brain (hypoxia) and death.


This is the number of lives lost in 2022 due malfunctioning medical devices or improper use.


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) Occlusion-related events

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 Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HVAD Systems HeartWare 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 batteries for HeartWare HVAD system.

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recalls HawkOne Directional Atherectomy System

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 Covered Stent

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc Recalls the SafeStar55 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

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
Website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/