Notes

Deadliest FDA Recalls 2022. - Lost Feeding Tubes Ahead (Avanos Medical)
Based on FDA recalls The Avanos Medical Cortrak2 feeding tube is the most dangerous medical device.

While 2022 isn't completed even though 2022 isn't over yet, the FDA has already prepared the list of 50 recalls for medical devices. The effect of these recalls thus far has been a tragic 36 deaths and more than 224 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions with 23 cases of deaths caused due to misplaced feeding tubes.


These are the most dangerous medical device errors according to the FDA recall notice:

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
Inadvertently taking out nasogastric tube feeding tubes caused 60 injuries and 23 deaths.

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


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


Patients are at risk of serious injury or even death if the nasogastric tube or nasoenteric tub is wrongly placed. To protect themselves, Avanos Medical sent the notice to healthcare professionals asking either the user or the facility "...confirm the position of the NG/NI tube according to institutional guidelines" Fox news reported.

Avanos Medical reported in a recall notice that fatalities and injuries were resulted from the incorrect placement or improper use of an feed tubes to the stomach while using the CORTRAK*2 Ental Access System.

Baxter recalls SIGMA Spectrum Infusion pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received 51 calls about serious injuries and three deaths of patients which could be linked to this issue in the past five years.

After numerous complaints of safety alarms malfunctioning The manufacturer of medical devices Baxter has recalled this device. In the event of an obstruction in the upstream the alarm was unable to be activated on the pumps. The warnings were issued that these products could have adverse health consequences and may even lead to death.

Avanos Medical Medtronic Recalls NIMCACT Reinforced Endotracheal Tube EMG
The device's use led to 3 injuries, and two deaths.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - both used to provide an airway to the patient and monitor the laryngeal nerves undergoing head and neck surgery - have been the source of three accidents and two deaths before Medtronic's recall. https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm Although the company doesn't require customers to return the defective products or replace them, they have sent out security alerts to ensure the silicone cuff didn't hinder a patient's breathing.


Patients can be affected by oxygen deprivation, brain damage or death if the tube doesn't ventilate effectively or block the airway.

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

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor in-line to ventilators could prevent patients at-home from getting enough oxygen. Patients who are affected include choking on mucus or other airway secretions, lung infections (pneumonia) which blocks oxygen from reaching the bloodstream (respiratory failure) as well as brain injury resulted from a lack of oxygen to the brain (hypoxia) as well as death.


Cortrak 2 eternal access system This is the list of human deaths in 2022 as a result of medical device malfunctions or abuse.


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) Occlusions

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced 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 4000 and 3500 Syringe Pumps for Infusion

Injuries: 7

Deaths: 1

Medtronic Recalls the HVAD Systems HeartWare Batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 and V60 Plus Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls the HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls batteries of the HeartWare HVAD system.

https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 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 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 bellavista1000 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


Website: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause