Notes

The FDA's most deadly recalls for 2022 - Incorrect Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are the most deadly medical devices according to FDA recalls.

While 2022 is not yet completed, FDA already has 50 medical devices listed on its recall list. This recall has resulted in the tragic deaths of 36 and 228 injuries. Avanos Medical is first on the list of 2022 for malfunctions with medical devices, with 23 deaths reported due to the wrong placement of feeding tubes.


The following are the top four risky medical device mistakes according to the FDA recall notification:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
A misplacement of the feed tubes for nasogastric patients resulted in 60 injuries and 23 fatalities.

This is the most frequent reason for death in recalled devices.


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.


If a nasogastric or Nasoenteric, tubes are improperly put in the wrong place, patients can suffer harm to their vocal cords, lungs, or trachea. This can cause serious injuries and even death. Avanos Medical issued a notification to doctors and other healthcare professionals to verify the location of the NG/NI tubes in accordance with the institution's procedure. Fox news announced.

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

https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ 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 reports of serious injuries, and three reports of patient deaths over five years potentially associated with this issue.

Following numerous complaints about safety alarms malfunctioning The manufacturer of medical devices Baxter has announced a recall of the device. The alarms on the pumps were not activating in the event of occlusions in the upstream. The announcement warned users that using the affected products could cause adverse health consequences, including death.

Avanos Medical Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been 3 injuries and 2 deaths that have been linked with the use of the device.

Two deaths and three injuries were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube both of which are used to monitor the laryngeal and head nerves. Avanos Medical feeding tube The company isn't asking clients to return or exchange the affected devices , but they have it has issued safety alerts to stop the device's silicone cuff from blocking an individual's airway.


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

Baxter Healthcare Corporation Recalls Volara System
There have been one injury and 2 deaths associated by the use of this device.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor on the line to ventilators can prevent patients who use the ventilator at home from getting sufficient oxygen. https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its There is a risk for the patients which include choking upon mucus and airway secretions, lung infection (pneumonia), which prevents oxygen from reaching the bloodstream (respiratory Failure), brain injury due to a lack in oxygen (hypoxia) and as well as death.


This is a list of human lives that will be paid in 2022 due to 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) and Spectrum IQ Infusion Systems (Version 9) obstructions

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 Implant 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. Cortrak 2 eternal access system Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Thrombolytic Percutaneous Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls the 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.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its