Notes

FDA's Deadliest Recalls 2022 The Misplaced Feeding Tubes Inspiring (Avanos Medical)
According to FDA recalls, Avanos's Medical Cortrak2 is the most hazardous medical device.

Even though 2022 isn't finished, the FDA has already put together the following list of recalls of medical devices. The recall has led to an unfortunate 36 deaths, and more than 224 injuries. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause?utm_medium=email&utm_source=govdelivery Avanos Medical ranks first on the list of 2022 medical device malfunctions with 23 deaths reported by misplaced feeding tubes.


These are the four deadliest medical device malfunctions as per the FDA medical device recall Notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Feeding Tubs
The incorrect placement of nasogastric feeding tubes led to the deaths of 23 and injuries to 60.

In 2022 , this device malfunction was the leading cause of death in all the medical equipment that was recalled.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injuries and deaths for patients who received Nasogastric and nasoenteric tubes that were not correctly placed.


In instances where a nasal or nasoenteric tube has been inserted improperly, patients may suffer injury to the vocal cords, lungs, or trachea, all of which could result in serious injury or even death. Avanos Medical notified that patients "...and hospitals should verify the positioning of N/NI tubes according to institutional guidelines. Fox News said.

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

Baxter recalls SIGMA Spectrum Infusion pumps that have Master Drug Library (Version 8) & Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter received 51 reports of serious injury and three reports on patient deaths within the last five years.

After numerous complaints of security alarms not working after numerous complaints of safety alarm malfunctions, the medical device maker Baxter has recalled this device. Avanos Medical Avanos Medical feeding tube The alarms on the pumps weren't triggering in the case of an upstream obstruction. These products can cause adverse health consequences that could lead to death as per the announcement.

Medtronic recalls NIMCACT reinforced Endotracheal Tube EMG
There have been 3 accidents and 2 deaths attributed with the use of this device.

Two deaths and three injuries resulted from the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube both of which are used to track the head and laryngeal nerves. Avanos Medical Although Medtronic doesn't ask clients to return the damaged products, the company sent out safety alerts in an effort to stop the cuff made of silicone to block a patient's airway.


If the tube is unable to adequately ventilate or block the airway, patients could suffer from deprivation of oxygen and brain damage or death.

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

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that an in-line ventilation adapter may hinder patients using home oxygen from receiving enough oxygen from their ventilators. The most vulnerable patients are those who breathe in mucus respiratory failure (pneumonia), brain injury (hypoxia), and breathing difficulties.


This is the number of lives lost 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 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 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 Pumps for Infusion

Injuries: 7

Deaths: 1

Medtronic recalls the HeartWare HVAD system batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus ventilatilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump Kit

Injuries: 2

Deaths: 1

Medtronic recalls HeartWare batteries 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 as 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 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 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


Here's my website: https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/