Notes

The FDA's most dangerous recalls of 2022 Unplaced Feeding Tubes Leading (Avanos Medical)
According to FDA recalls, the Avanos Medical Cortrak2 is the most hazardous medical device.

The year 2022 hasn't come to an end, and the FDA's list of recalled medical devices stands at 50. The effect of the recalls to date has been a tragic 36 deaths and the number of injuries is 224. Avanos Medical is first on the list of 2022 for malfunctions in medical devices, with 23 reported deaths due to feeding tubes that were not properly placed.


These are the four deadliest medical device malfunctions as per the FDA medical device recall notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Misplacement of nasogastric feed tubes caused 60 injuries and 23 fatalities.

The malfunction of this device is the most significant 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 injuries and deaths in patients who received nasogastric or nasoenteric feeding tubes that were placed incorrectly.


Patients are at risk of serious injury or even death, if a nasal tub or nasoenteric one is wrongly placed. Avanos Medical notified that patients "...as well as hospitals must verify the placement of N/NI tubes according to institutional guidelines. Fox News reported.

Avanos Medical's recall communications included the fatalities and injuries caused by the misplacement of the tubes feeding into the enteral lining in the CORTRAK* 2 Enteral Access System from 2015.

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received 51 complaints concerning serious injuries and three reports regarding patient deaths that could be connected to this issue over the last five years.

Avanos Medical The medical device manufacturer Baxter has recalled the device after numerous complaints of a security alarm malfunction. Alarms on the pumps weren't triggering in the case of occlusions in the upstream. These substances can have adverse health effects that could cause death, according to the announcement.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its Medtronic Recalls NIM CONTACT Reinforced Endotracheal Tube with EMG
The device has been linked to three injuries and two deaths.

Three injuries and two deaths resulted from the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube which are used to monitor laryngeal and head nerves. The company isn't asking customers to return or swap the affected devices , but they have they have issued safety announcements to keep the device's cuff from blocking a patient's airway.


Patients could suffer from cerebral injury, oxygen deprivation, or even death if tube is not ventilated appropriately.

Avanos Mediacal Cortrak 2 Baxter Healthcare Corporation Recalls Volara System
This device has been associated with 1 injury and 2 deaths.

Avanos Mediacal Cortrak 2 Baxter Healthcare Corporation, and Hillrom its subsidiary company, are recalling the Volara Systems. This is because the adaptor for inline ventilators could not allow patients with home use to get enough oxygen. Patients who are affected include choking on mucus or other airway mucus, lung infection (pneumonia) which prevents oxygen from reaching the bloodstream (respiratory failure) and brain injuries caused by lack of oxygenation to the brain (hypoxia) and even death.


https://www.medicaltubingandextrusion.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ This is a list of people's lives that were lost because of medical device failure or misuse in 2022.


Avanos Medical 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) occlusion events

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 Remands 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 the HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls the HeartWare batteries HVAD system.

Avanos Mediacal Cortrak 2 Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC is a subsidiary of Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Covered Stent

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 SafeStar 55 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

Cortrak 2 eternal access system
Homepage: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its