Notes

FDA's Most Dangerous Recalls in 2022 - Unplaced Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most deadly medical devices as per FDA recalls.

Although 2022 is still not completed even though 2022 isn't over yet, the FDA has already created the list of 50 recalls for medical devices. https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ The recalls have led to 36 deaths and 228 injuries. Avanos Medical is first on the list of 2022 for malfunctions with medical devices, with 23 deaths attributed to faulty feeding tubes.


The four most deadly medical device malfunctions , according to the FDA medical device recall notice:

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

Avanos Medical feeding tube In 2022 the year 2022, this malfunction was the most significant reason for death among all the medical equipment that was recalled.


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


Patients could be seriously injured or even death if the nasogastric tube or nasoenteric tub is incorrectly inserted. https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas Avanos Medical notified that users "...and hospitals must confirm the location of N/NI tubes according the guidelines of the institution. Avanos Medical Fox News reported.

Avanos Medical's recall communications reported that the CORTRAK*2 Accessory System has been misplaced by enteral tube feeding 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, and three cases of patient deaths that could be related to this problem over the past 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. A warning was issued that these items could have negative health effects and even death.

Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been three injuries and 2 deaths that have been linked by the use of this device.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube Both designed to improve airway flow and monitor laryngeal nervous systems during head and neck surgery caused three fatalities and two injuries before Medtronic's recall. Although Medtronic isn't asking for customers to return damaged devices, it has sent out safety alerts to try to prevent the silicone cuff in the patient's airway.


Patients can experience cerebral injury, oxygen deprivation, or even death if the tube is not ventilated properly.

Baxter Healthcare Corporation Recalls Volara System
This device has been linked with 2 accidents and one injury. deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that an in-line ventilation adaptor could hinder home-based patients in getting enough oxygen from their ventilators. Patients at risk include people who breathe mucus and respiratory failure (pneumonia) and brain injury (hypoxia), and choking.


This is the list of human deaths in 2022 due to medical device malfunctions or misuse.


Cortrak 2 eternal access system Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps With Master Drug Library (Version 8) & Spectrum IQ Infusion Systems With Dose IQ Safety Software(Version 9) the occlusions

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 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 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 Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola percutaneous thrombolytic 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

Cortrak 2 eternal access system
Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/