Notes

FDA's Most Dangerous Recalls 2022: Misplaced Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most deadly medical devices according to FDA recalls.

Although 2022 isn't yet completed, FDA already has 50 medical devices on the recall list. The result of these recalls as of now is an unfortunate 36 deaths and more than 224 injuries. Avanos Medical ranks number one on the 2022 list of malfunctions in medical devices with 23 deaths related to the wrong placement of the feeding tube.


These are the 4 most risky medical device mistakes according to the FDA recall notification:

Avanos Medical Remands Cortrak*2 Enal Access System for Feeding Tubs
Inadvertently removing the nasogastric feeding tube tubes resulted in 60 injuries and 23 deaths.

Cortrak 2 eternal access system This is the leading cause of death among recalled devices.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due to the risk of injuries and deaths caused by incorrect placement of nasogastric feed tubes.


Patients are at risk of serious injury or even death if a nasogastric tube or nasoenteric tub is improperly placed. Avanos Medical issued a notification to requesting that providers confirm the positioning of the NG/NI tube per institutional procedure. Fox news announced.

Avanos Medical's recall communications stated the deaths and injuries that resulted from the misplacement the tubes feeding into the enteral lining during the use of the CORTRAK* 2 Enteral Access System as of 2015.

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

Avanos Medical feeding tube https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its The medical device manufacturer Baxter Recalled this device following numerous reports of a safety alarm malfunction. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding The alarms on the pumps were not being activated in case of upstream occlusion events. A warning was issued that these products could cause adverse health effects and could even cause death.

Cortrak 2 eternal access system Medtronic Recalls NIMCACT Reforced Endotracheal Tube EMG
The device has been associated with 3 injuries and 2 fatalities.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to provide an airway as well as monitor laryngeal nerves in head and neck surgeries - were the cause of three injuries and two deaths before Medtronic's recall. The company isn't asking customers to return or replace the affected devices , but it has sent out safety notices to keep the device's cuff from blocking an individual's airway.


If the tube does not ventilate properly or obstructs the airway, patients can be suffering from oxygen deprivation as well as brain damage, and even death.

Cortrak 2 eternal access system Baxter Healthcare Corporation Recalls Volara System
There has been 1 accident and 2 deaths that have been linked 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 for in-line ventilators may not allow patients who use at-home ventilators to receive enough oxygen. There are risks for affected patients such as choking on mucus or other airway fluids, lung infection (pneumonia), which prevents oxygen from reaching the blood (respiratory Failure) as well as brain injury due to lack of oxygen (hypoxia), as well as death.


This is a list containing the human lives lost because of medical device failure or misuse in 2022.


Avanos Medical Remcalls Cortrak*2 Entry 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) occlusions

Injuries: 51

Deaths: 3

Medtronic recalls NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement , as well as the NIM Standard Reinforced 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 HVAD HeartWare system batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump Kit

Injuries: 2

Deaths: 1

Medtronic recalls the batteries of the HeartWare HVAD system

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast secured sten

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

Cortrak 2 eternal access system Avanos Medical
Homepage: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its