Notes

The FDA's most deadly recalls for 2022 - Unplaced Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, the Avanos Medical Cortrak2 is among the most dangerous medical device.

https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A The year 2022 hasn't come to an end, yet the list of recalls by the FDA for medical devices is already at 50. The effect of these recalls thus far is unfortunate, with 36 deaths and 228 injuries. Avanos Medical ranks first on the list of 2022 medical device malfunctions with 23 reports of deaths caused due to misplaced feeding tubes.


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

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

This is the most common cause of death for recalled devices.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due to injuries and deaths resulting from the incorrect placement of nasogastric feed tubes.


Avanos Medical feeding tube Patients could suffer serious injury or even death, if a nasal tub or nasoenteric tube is incorrectly inserted. Avanos Medical notified that users "...as well as hospitals should confirm the placement of the N/NI tubes according to hospital protocol. Fox News reported.

Cortrak 2 eternal access system Avanos Medical's recall communications stated the deaths and injuries due to the misplacement the feed tubes to the stomach while using the CORTRAK* 2 Enteral Access System as of 2015.

Baxter recalls SIGMA Spectrum Infusion pumps equipped with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter received 51 serious injuries as well as three reports of death of patients in the past five years.

Baxter, a company that makes medical devices has announced a recall of the device after numerous reports of a safety alarm failure. The alarm on the pumps was not able to activate in the event of upstream obstruction events. It was warned that the products could cause adverse health effects and even death.

Medtronic Recalls EMG Reinforced Endotracheal Tube
The device's use led to 3 injuries, and 2 deaths.

Avanos Medical feeding tube Avanos Medical The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube Both utilized to help provide airway and monitor laryngeal nervous systems during head and neck surgery caused three deaths and three injuries before Medtronic's recall. Although the company doesn't ask customers to return the defective devices or to replace them, they have sent out safety alerts to make sure the silicone cuff did not hinder a patient's breathing.


https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas If the tube doesn't vent properly or block the airway, patients might suffer from deprivation of oxygen, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System
There have been one death and 1 injury by the use of this device.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the in-line ventilator adaptor could hinder home-based patients from receiving enough oxygen from their ventilators. Cortrak 2 eternal access system The most vulnerable patients are those who breathe in mucus respiratory failure (pneumonia), brain injuries (hypoxia), and the possibility of choking.


Here is the list of human life-saving costs in 2022 for medical device malfunction or misuse:


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps (Version 8) & Spectrum IQ Infusion Systems (Version 9) Occlusions

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube as well as 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 the HVAD Systems HeartWare Batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus ventilatilators

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. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC, 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 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

Cortrak 2 eternal access system
Read More: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/