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FDA's Most Dangerous Recalls in 2022 - Unplaced Feeding Tubes Inspiring (Avanos Medical)
According to FDA recalls, Avanos ' Medical Cortrak2 is the most dangerous medical device.

Avanos Medical feeding tube Avanos Medical Although 2022 is still not finished The FDA has already prepared a list of 50 recalled medical devices. This recall resulted in the tragic deaths of 36 and 224 injuries. Avanos Medical ranks first on the 2022 list of medical device failures with 23 cases of deaths caused by feeding tubes that were not properly placed.


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

Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
Inadvertently removing nasogastric feeding tube tubes caused 60 injuries and 23 deaths.

In 2022 the year 2022, this malfunction was the most significant cause of death in all recalled medical equipment.


Avanos Mediacal Cortrak 2 Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of deaths and injuries from patients who received nasogastric or nasoenteric feeding tubes that were improperly placed.


In cases where a nasogastric or nasoenteric tube is inserted in a way that is not correct, patients can suffer injuries to the vocal cords, the lungs, or trachea. All of which can lead to serious injuries or even death. To protect themselves, Avanos Medical sent warning to doctors to suggest that the user or the hospital "...confirm the positioning of the NG/NI tube according to institutional protocols" Fox news reported.

Avanos Mediacal Cortrak 2 https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system Avanos Medical's recall notification stated the deaths and injuries related to the misplacement of the enteral feeding tubes while using the CORTRAK* 2 Enteral Access System from 2015.

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)
Baxter has received reports concerning serious injuries and three deaths of patients which could be linked to this concern over the last five years.

Following numerous complaints about safety alarms malfunctioning and malfunctions in safety alarms, the manufacturer of medical devices Baxter has decided to recall the device. The alarm on the pumps was unable to sound in the event of upstream obstruction events. These products could cause negative health effects , which could lead to death according to the announcement.

Medtronic Recalls NIM Contact Reinforced Endotracheal Tube with EMG
The device has been linked to 3 deaths and 2 injuries.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube Both used to provide airway and monitor laryngeal nervous systems during head and neck surgery - were responsible for three injuries and two fatalities prior to Medtronic's recall. Although the company doesn't require customers to return the defective devices or to replace them, it sent out security alerts to ensure the silicone cuff didn't block a patient's airway.


Patients can suffer from oxygen deprivation, brain damage or even death when the tube does not ventilate properly or block the airway.

Baxter Healthcare Corporation Recalls Volara System
There have been one accident and 2 deaths that have been linked 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 not getting enough oxygen through their ventilators. Avanos Mediacal Cortrak 2 Patients at risk include those who breathe in mucus or respiratory failure (pneumonia) or brain injury (hypoxia) and the possibility of choking.


Avanos Medical feeding tube This is the list of human deaths in 2022 as a result of medical device malfunctions or abuse.


Avanos Medical Recalls Cortrak*2 Ental 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 NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement , as well as the NIM Standard Reinforced 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 HeartWare HVAD System 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 of the HeartWare HVAD system

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Medtronic Inc.

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast that covered sten

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 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


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