Notes

FDA's Most Dangerous Recalls in 2022 - Misplaced Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, Avanos's Medical Cortrak2 is among the most dangerous medical device.

https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ While 2022 isn't completed, the FDA has already prepared an inventory of 50 recalls of medical devices. This recall resulted in the tragic deaths of 36 and the injury of 224. 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.


These are the four most serious medical device malfunctions, according to the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
A misplacement of the feed tubes for nasogastric patients resulted in 60 injuries and 23 fatalities.

This device malfunction is the leading cause of death in all recalled medical devices by the FDA in 2022..


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service because of the risk of injuries and deaths caused by the incorrect placement of nasogastric feed tubes.


In the event that a nasogastric or nasoenteric tube is inserted improperly, patients may suffer damage to the vocal cords, the lungs, or trachea. Any of which could cause serious injuries or even death. Avanos Medical notified that patients "...and hospitals must verify the placement of N/NI tubes according to the guidelines of the institution. Fox News reported.

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

Avanos Mediacal Cortrak 2 Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received 51 complaints regarding serious injuries as well as three deaths of patients which could be linked to this concern over the past five years.

Avanos Medical feeding tube Following numerous complaints about malfunctioning safety alarms after numerous complaints of safety alarm malfunctions, the medical device maker Baxter has announced a recall of the device. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 In the event of an upstream obstruction the alarm was unable to be activated on the pumps. These products can cause adverse health effects , which could result in death as per the announcement.

Medtronic recalls EMG reinforced Endotracheal Tube
This device has been associated with 3 injuries and 2 fatalities.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube both used to provide airway and laryngeal nerve systems during neck and head surgery was responsible for three fatalities and two injuries before Medtronic's recall. Although Medtronic doesn't ask its customers to return their damaged products, the company sent out safety notices in order to prevent the cuff made of silicone to block a patient's airway.


Patients can experience cerebral injury, oxygen deprivation or even death if the tube is not ventilated properly.

Baxter Healthcare Corporation Recalls Volara System
The use of this device lead to 2 injuries and 2 deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor in-line to ventilators could prevent patients who use the ventilator at home from getting enough oxygen. The potential risks for affected patients include choking on mucus or other airway secretions lung infections (pneumonia) that prevents oxygen from reaching the blood (respiratory failure) or brain injury caused by lack of oxygenation to the brain (hypoxia) as well as death.


Avanos Mediacal Cortrak 2 This is a list of human life paid in 2022 for mishaps with medical devices or improper use:


Avanos Medical Remcalls Cortrak*2 Entry Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) & 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 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 and 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 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. Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Thrombolytic Percutaneous Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast secured sten

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista 1000 Series and 1000e 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


Homepage: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its