Notes

FDA's Deadliest Recalls 2022 – Incorrect Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are the most dangerous medical devices, according to FDA recalls.

Although 2022 is still not yet over even though 2022 isn't over yet, the FDA has already prepared a list of 50 recalled medical devices. The impact of these recalls as of now is an unfortunate 36 deaths and more than 224 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions with 23 reports of deaths caused due to misplaced feeding tubes.


These are the four most serious medical device malfunctions, according to the FDA recall notice.

Avanos Medical Remands Cortrak*2 Enal Access System for Feeding Tubs
The incorrect placement of nasogastric feeding tubes caused the deaths of 23 and injuries to 60.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf The device's malfunction is the most significant reason for death among all recalled medical devices by the FDA in 2022..


Avanos Mediacal Cortrak 2 Avanos Medical feeding tube Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of deaths and injuries in patients who received nasogastric or nasoenteric feeding tubes that were incorrectly placed.


If a nasogastric or nasoenteric tube has been inserted incorrectly, patients might suffer injury to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death. Avanos Medical notified that users "...and hospitals must verify the placement of N/NI tubes according hospital protocol. Avanos Mediacal Cortrak 2 Fox News covered the story.

Avanos Medical's recall announcement stated the deaths and injuries due to the misplacement the feed tubes to the stomach in 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 has received 51 complaints of serious injuries, and three cases of patient deaths that could be related to this issue over the last five years.

After numerous complaints of malfunctioning safety alarms, the manufacturer of medical devices Baxter has announced a recall of the device. Alarms on the pumps weren't being activated in case of occlusions in the upstream. The announcement warned that using the affected products could cause negative health effects, such as death.

Medtronic Recalls EMG Reinforced Endotracheal Tube
The device has been associated with three injuries and two deaths.

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to provide an airway and to monitor the laryngeal nerves undergoing head and neck surgeries - were the cause of three injuries and two deaths in the lead up to Medtronic's recall. The company hasn't asked clients to replace or return the affected devices but they have issued safety announcements to ensure that the device's silicon cuff from blocking a patient's airway.


Patients can suffer from the deprivation of oxygen, brain injuries or even death if tube is not ventilated appropriately.

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

Avanos Medical Baxter Healthcare Corporation, and Hillrom the subsidiary company, are recalling the Volara Systems. Avanos Mediacal Cortrak 2 This is because the adaptor used for in-line ventilators may not allow patients using at-home devices to receive sufficient oxygen. There are risks for patients affected which include choking upon mucus and airway secretions and lung infection (pneumonia), which prevents oxygen from reaching the bloodstream (respiratory Failure), brain injury due to lack of oxygen (hypoxia) as well as death.


This list contains human lives that were lost because of medical device malfunction 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) Occlusion-related events

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube, and the NIM Standards Reinforced-EMG 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 the HeartWare HVAD system batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic recalls the 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. Medtronic Inc.

Injuries: 55

Deaths: 0

Arrow International, LLC, Subsidiary to Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic 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 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


Read More: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/