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Deadliest FDA Recalls 2022. - Lost Feeding Tubes Inspiring (Avanos Medical)
According to FDA recalls Avanos Medical's Cortrak2 feeding tube is the most deadly medical device.

Although 2022 is still not yet over The FDA has already put together the list of 50 recalls for medical devices. The recalls have led to 36 deaths and the injury of 224. Avanos Medical ranks first on the list of 2022 medical device malfunctions with 23 deaths reported by misplaced feeding tubes.


They are the four most grave medical device malfunctions in accordance with the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
Incorrect placement of nasogastric feed tubes led to 60 injuries and 23 deaths.

The malfunction of this device is the main cause of death for all recalled medical devices by the FDA in 2022.


Avanos Medical Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and deaths resulting from nasoenteric and nasogastric feeding tubes were put in the wrong place.


If a nasogastric or the nasoenteric tube is not correctly put in the wrong place, patients can be harmed by their vocal cords, lungs, or trachea. This could cause severe damage and even death. In order to protect themselves, Avanos Medical sent notice to providers to suggest that the hospital or user "...confirm the placement of the NG/NI tube according to hospital protocol" Fox news reported.

Avanos Medical's recall announcements stated that the CORTRAK*2 Enteral Access System has been misplaced enteral tube feeding since the year 2015.

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 calls concerning serious injuries and three deaths of patients which could be linked to this concern over the past five years.

The medical device maker Baxter Recalled this device after numerous complaints of a security alarm malfunction. The alarm on the pumps failed to be activated in the case of upstream occlusions. Avanos Medical A warning was issued that these products could result in adverse health effects , and possibly even death.

Medtronic recalls EMG reinforced Endotracheal Tube
There have been 3 injuries and 2 deaths associated by the use of this device.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube Both utilized to supply airway and to monitor the laryngeal nervous system during neck and head surgery and head surgery - caused three injuries and two fatalities prior to Medtronic's recall. Although Medtronic doesn't ask customers to return damaged products, the company sent out safety notices in order to prevent the silicone cuff in the patient's airway.


Avanos Medical feeding tube Patients can experience an oxygen deficiency, brain injury or even death if the tube is not ventilated appropriately.

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

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the in-line ventilator adapter may hinder patients using home oxygen in getting enough oxygen from their ventilators. There are some risks for those affected that include choking on mucus and other airway secretions or lung infections (pneumonia) which blocks oxygen from reaching the bloodstream (respiratory Failure) and brain injuries because of a lack of oxygen (hypoxia), in addition to death.


This is the list of human lives lost in 2022 due 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) 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 and the NIM Standard 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 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 Kit

Injuries: 2

Deaths: 1

Medtronic recalls the HeartWare HVAD Systems Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Avanos Medical feeding tube Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC, Subsidiary to Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stent Covered

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


Read More: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/
     
 
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