Notes

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

Although 2022 isn't over, FDA already has 50 medical devices on the recall list. This recall has caused an unfortunate 36 deaths, and more than 224 injuries. Avanos Medical is first on the 2022 list for medical device malfunctions, with 23 reported deaths due to faulty feeding tubes.


These are the most risky medical device mistakes in accordance with the FDA recall notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently removing the nasogastric feeding tube tubes led to 60 injuries and 23 deaths.

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


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of deaths and injuries for patients who received Nasogastric and nasoenteric tubes that were placed incorrectly.


In instances where a nasal or nasoenteric tube is inserted improperly, patients may suffer injuries to the vocal cords, lungs, or trachea, all which can lead to serious injury or even death. Avanos Medical notified that users "...and hospitals should verify the positioning of N/NI tubes as per the guidelines of the institution. Fox News reported.

Avanos Medical reported in a recall notice that deaths and injuries were resulted from the incorrect placement or use of tubes for feeding into the enteral system when using the CORTRAK*2 Ental Access System.

Avanos Medical Avanos Medical feeding tube Baxter recalls SIGMA Spectrum Infusion pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received 51 complaints of serious injuries as well as three cases of deaths in the past five years that could be associated with this issue.

Avanos Medical The medical device maker Baxter has recalled the device following numerous reports of a malfunctioning alarm. In the event of an obstruction to the flow of the water the alarm could not activate on the pumps. It was warned that the products could have adverse health effects and even death.

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube with EMG
The use of the device resulted in 3 injuries and 2 deaths.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube that are used to open an airway and monitor laryngeal nerves in head and neck surgery - are the cause of three injuries and two deaths in the lead up to Medtronic's recall. Even though Medtronic hasn't requested its customers to return their damaged products, the company sent out safety notices in an effort to stop the cuff made of silicone in the patient's airway.


Patients can be affected by cerebral damage, oxygen deprivation or death in the event that the tube isn't ventilating properly or block the airway.

https://www.transtats.bts.gov/exit.asp?url=https://anotepad.com/notes/6kqshmi3 Cortrak 2 eternal access system Baxter Healthcare Corporation Recalls Volara System
There have been one incident of injury and 2 deaths by the use of this device.

Baxter Healthcare Corporation, and Hillrom its subsidiary company are recalling the Volara Systems. The reason for this is that the adaptor that is used to connect in-line ventilators is not allowing home-use patients to get enough oxygen. There are risks for affected patients, including choking on mucus and airway secretions and lung infection (pneumonia) that blocks oxygen from reaching the blood (respiratory failure), brain injury caused by a lack of oxygen (hypoxia) and as well as death.


This is a list containing the human lives lost due to medical device malfunction or misuse in 2022.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

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

Injuries: 51

Deaths: 3

Medtronic Recalls NIMCONTACT Reinforced Endotracheal Tube that has EMG Reinforcement and 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 Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the 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 the HVAD Systems HeartWare Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Avanos Mediacal Cortrak 2 Avanos Mediacal Cortrak 2 Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC is a subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls the iCast Stent, which is covered by iCas

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 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


Read More: https://independent.academia.edu/MiddletonHowe1