Notes

FDA's Deadliest Recalls 2022 – Food Feeding Tubes The most feared (Avanos Medical)
According to FDA recalls, the Avanos Medical Cortrak2 is among the most hazardous medical device.

While 2022 is not yet over, FDA already has 50 medical devices on the recall list. Avanos Medical This recall has caused the tragic deaths of 36 and 228 injuries. Cortrak 2 eternal access system Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 reported deaths from unintentionally placed feeding tubes.


These are the 4 deadliest medical device malfunctions according to the FDA medical device recall Notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
The misplacement of the nasogastric feed tube resulted in 60 injuries, and 23 fatalities.

The device's malfunction is the leading cause of death of all recalls of medical devices by the FDA in 2022.


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


In cases where a nasogastric or nasoenteric tubes is inserted incorrectly, patients could experience injuries to the vocal cords, lungs or trachea, all of that could lead to severe injury or even death. Avanos Medical issued a announcement to requesting that providers verify the placement of the NG/NI tubing according to the institution's procedure. Avanos Medical feeding tube https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Fox news reported.

Avanos Medical's recall announcements stated that the CORTRAK*2 Accessory System has been missing enteral feeding tubes since the year 2015.

Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries. There were three cases of deaths over the course of five years, which could be linked with this problem.

Baxter, a manufacturer of medical devices , has recalled the device following numerous reports of a failure in the safety alarm. Avanos Medical Alarms on the pumps were not triggering in the case of occlusions in the upstream. The announcement warned that use of these affected products could result in negative health effects, such as death.

https://www.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/ Medtronic recalls NIM CONTACT Reinforced EMG Endotracheal Tube
The use of the device resulted in 3 injuries as well as 2 deaths.

Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube both of which are used to check the head and laryngeal nerves. Although the company doesn't ask customers to return defective devices or exchange them, it sent out safety alerts to make sure the silicone cuff didn't impair a patient's airway.


Patients can be affected by oxygen deprivation, brain damage or even death when the tube does not ventilate well or blocks the airway.

Baxter Healthcare Corporation Recalls Volara System
The use of this device lead to 2 injuries and 2 deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor in-line to ventilators could prevent patients at-home from getting sufficient oxygen. There is a risk for the patients which include choking upon mucus as well as other airway secretions or lung infections (pneumonia), which prevents oxygen from getting into the blood (respiratory Failure) or brain injury because of a lack of oxygen (hypoxia) and as well as death.


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


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps (Version 8) & Spectrum IQ Infusion Systems (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 Pumps for Infusion

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 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. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC, Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stents that are covered

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista 1000 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

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