Notes

The FDA's most deadly recalls for 2022 - Food Feeding Tubes Inspiring (Avanos Medical)
As per FDA recalls, Avanos's Medical Cortrak2 is among the most dangerous medical device.

2022 hasn't yet come to an end yet, however the FDA's list of recalled medical devices stands at 50. The impact of these recalls thus far is an unfortunate 36 deaths and 228 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions , with 23 deaths reported by misplaced feeding tubes.


These are the 4 deadliest medical device malfunctions according to the FDA medical device 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.

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


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


If a nasogastric or nasoenteric tubes is inserted incorrectly, patients could experience injuries to the vocal cords, the lungs, or trachea. Any of which could result in serious injury or even death. As a precaution, Avanos Medical sent warning to doctors asking either the user or the facility "...confirm the placement of the NG/NI tube according to the institution's protocols" Fox news reported.

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

Baxter recalls SIGMA Spectrum Infusion Pumps that have Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter received 51 serious injuries and three reports on patient deaths in the past five years.

After numerous complaints of security alarms not working The medical device manufacturer Baxter has announced a recall of this device. The alarm on the pumps was unable to activate in the event of occlusions in the upstream. These substances can have adverse health effects , which could cause death according to the announcement.

Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been three incidents of injury and two deaths with the use of the device.

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - both used to open an airway to the patient and monitor the laryngeal nerves in head and neck surgeries - have been the cause of three injuries and two deaths in the lead up to Medtronic's recall. https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas Avanos Medical feeding tube Even though Medtronic hasn't requested customers to return damaged devices, the company sent out safety notices to try to prevent the silicone cuff from blocking a patient’s airway.


Cortrak 2 eternal access system Patients can experience oxygen deprivation, brain injury, or even death , if the tube is not ventilated properly.

Avanos Medical feeding tube Baxter Healthcare Corporation Recalls Volara System
There was one death and 1 injury with the use of this device.

Baxter Healthcare Corporation, and Hillrom, its subsidiary company, are recalling the Volara Systems. This is due to the fact that the adaptor that is used to connect in-line ventilators could not allow home-use patients to get enough oxygen. Patients who are affected include choking on mucus or other airway secretions lung infections (pneumonia) which blocks oxygen from getting to the blood (respiratory failure) as well as brain injury resulted from a lack of oxygenation to the brain (hypoxia) and death.


This is the list of human deaths in 2022 due medical device malfunctions or misuse.


https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system Avanos Medical Recalls Cortrak*2 Enteral 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 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 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 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.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls ICast, a Stent that is covered by the iCa

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 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


Here's my website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/