Notes

The most deadly FDA Recalls 2022 - Misplaced Feeding Tubes Leading (Avanos Medical)
According to FDA recalls The Avanos medical Cortrak2 feeding tube is among the top deadliest medical device.

Although 2022 is still not finished, the FDA has already prepared a list of 50 recalled medical devices. The recalls have caused 36 deaths and 228 injuries. Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 deaths related to an improperly placed feeding tube.


They are the deadliest medical device malfunctions , according to the FDA medical device recall notification:

Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
Inadvertently taking out nasogastric tube feeding tubes resulted in 60 injuries and 23 deaths.

The device's malfunction is the main cause of death of all medical devices that were recalled by the FDA in 2022.


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


If a nasogastric, also known as a the nasoenteric tube is not correctly placed, patients could suffer damage to their vocal cords, lungs, or the trachea. Cortrak 2 eternal access system It could result in severe injury 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 institutional procedure. Cortrak 2 eternal access system Fox news announced.

Avanos Medical's recall communications stated the deaths and injuries that resulted from the misplacement the enteral feeding tubes when using the CORTRAK* 2 Enteral Access System since 2015.

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

Baxter, a manufacturer of medical devices recalls the device following numerous reports of a safety alarm failure. The alarms on the pumps were not being activated in case of occlusions in the upstream. https://www.jdsupra.com/legalnews/avanos-medical-pays-22-million-to-6295757/ Warnings were made that these items could have negative health effects and even death.

Avanos Medical Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been 3 accidents and 2 deaths attributed to the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - which are used to provide an airway and to monitor the laryngeal nerves in head and neck surgery - have been responsible for three injuries and two deaths prior to Medtronic's recall. While Medtronic hasn't asked customers to return damaged products, the company issued safety warnings to help prevent the silicone cuff in the patient's airway.


If the tube fails to ventilate properly or obstructs the airway, patients may be afflicted with oxygen deprivation, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has led to 1 injury, 2 deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor on the line to ventilators can prevent home-use patients getting sufficient oxygen. Patients who are affected are choking on mucus, or other airway fluids, lung infections (pneumonia) which prevents oxygen from getting to the blood (respiratory failure), brain injury caused by a lack in oxygen to the brain (hypoxia) and death.


This is the list of human deaths in 2022 due malfunctioning medical devices or improper use.


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps that come 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 NIMCONTACT Reinforced Endotracheal Tube with EMG Reinforcement and 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 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. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns Medtronic Inc.

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 iCast with a sten cover.

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista1000e 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


Here's my website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding