Notes

FDA's most dangerous recalls of 2022 - Misplaced Feeding Tubes Ahead (Avanos Medical)
According to FDA recalls, Avanos Medical Cortrak2 is the most hazardous medical device.

While 2022 is not yet completed, FDA already has 50 medical devices listed on the recall list. These recalls have resulted in 36 deaths and 224 injuries. Avanos Medical 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 dangerous medical device safety errors, in accordance with the FDA recall notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
A misplacement of the feed tubes for nasogastric patients led to 60 injuries and 23 deaths.

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


Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and patient death after nasoenteric feeding tubes have been improperly placed.


Patients could suffer serious injury or even death if the nasogastric tub or nasoenteric one is wrongly inserted. Avanos Medical feeding tube Avanos Medical issued a note to doctors and other healthcare professionals to verify the placement of the NG/NI tube per institutional procedure. Fox news reported.

Avanos Medical's recall notification stated the deaths and injuries that resulted from the misplacement the tubes feeding into the enteral lining while using the CORTRAK* 2 Enteral Access System, which was introduced in 2015.

Cortrak 2 eternal access system feeding tube placement 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 51 calls of serious injuries, and three reports of deaths in patients that could be connected to this issue in the last five years.

After numerous complaints of safety alarm malfunctions The medical device maker Baxter has decided to recall the device. Alarms on the pumps were not triggering in the case of occlusions in the upstream. A warning was issued that these items could have negative health effects and could even cause death.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
This device has been associated with 3 injuries and 2 fatalities.

Avanos Medical feeding tube The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to provide an airway to the patient and monitor the laryngeal nerves during head or neck surgeries - have been the source of three accidents and two deaths prior to Medtronic's recall. Even though Medtronic hasn't requested its customers to return their defective devices, the company sent out safety notices in order to prevent the silicone cuff from blocking the airway of a patient.


Patients may experience an oxygen deficiency, brain injury or even death if tube is not ventilated appropriately.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has 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 an in-line ventilation adapter may hinder patients using home oxygen in getting enough oxygen from their ventilators. There is a risk for the patients that include choking on mucus and airway secretions, lung infection (pneumonia) which blocks oxygen from getting into the bloodstream (respiratory Failure) or brain injury caused by a lack of oxygen (hypoxia) as well as death.


This is the number of lives lost in 2022 because of medical device malfunctions or misuse.


Avanos Medical Avanos Medical Recalls Cortrak*2 Enteral 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 Endotracheal Tube, and the NIM Standards 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 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 HeartWare HVAD System Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Avanos Medical Recalls the Arrow-Trerotola percutaneous thrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stent Covered

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 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


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