Notes

FDA's Most Dangerous Recalls in 2022 - Incorrect Feeding Tubes Inspiring (Avanos Medical)
Based on FDA recalls Avanos Medical's Cortrak2 feeding tube is the highest-risk medical device.

Although 2022 isn't over, FDA already has 50 medical devices listed on the recall list. The impact of the recalls so far is unfortunate, with 36 deaths and the number of injuries is 224. Avanos Medical ranks first on the 2022 list of medical device failures with 23 deaths reported due to misplaced feeding tubes.


The following are the top four dangerous medical device errors according to the FDA recall notification:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
The incorrect placement of nasogastric tube feeding caused the deaths of 23 and injuries to 60.

Avanos Mediacal Cortrak 2 In 2022 the year 2022, this malfunction was the primary cause of death in all recalls of medical equipment.


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


If a nasogastric or nasoenteric tubes is inserted in a way that is not correct, patients can suffer harm to their vocal cords, lungs or trachea. All of which could cause serious injury or death. Avanos Medical notified that patients "...and hospitals should verify the positioning of the N/NI tubes according institution protocol. Fox News reported.

Avanos Medical's recall notifications stated that the CORTRAK*2 Accessory System has been misplaced enteral tube feeding since the year 2015.

Baxter recalls SIGMA Spectrum Infusion Systems along with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries. There were three reports of patient deaths over five years potentially associated with this problem.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 After numerous complaints of safety alarms malfunctioning and malfunctions in safety alarms, the medical device maker Baxter has decided to recall the device. If there was an obstruction in the upstream the alarm did not be activated on the pumps. It was warned that the products could result in adverse health effects , and possibly even death.

Medtronic Recalls NIM Contact Reinforced Endotracheal Tube with EMG
The use of the device led to 3 injuries, and 2 deaths.

Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube both of which are used to track the laryngeal and head nerves. Although Medtronic isn't asking for customers to return damaged products, the company sent out safety notices to help prevent the silicone cuff to block a patient's airway.


Patients can suffer from the deprivation of oxygen, brain injuries, or even die if the tube isn't ventilated correctly.

Baxter Healthcare Corporation Recalls Volara System
The use of this device lead to 2 injuries, and 1 deaths.

Avanos Medical feeding tube https://www.medicalbuyer.co.in/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/ Baxter Healthcare Corporation, and Hillrom the subsidiary company, have recalled the Volara Systems. This is because the adaptor used for in-line ventilators might not permit patients who use at-home ventilators to receive enough oxygen. There are some risks for those affected that include choking on mucus and other airway secretions as well as lung infections (pneumonia) that prevents oxygen from reaching the blood (respiratory Failure), brain injury because of a lack of oxygen (hypoxia), along with death.


This is the list of human deaths in 2022 due to the malfunction of medical devices or their misuse.


Avanos Medical Recalls Cortrak*2 Enteral 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-EMG 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 4000 and 3500 Syringe Infusion Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HVAD Systems HeartWare 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 the HeartWare HVAD Systems Batteries

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 to Teleflex Inc., Recalls the Arrow Trarotola Percutaneous Thorolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast secured sten

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 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


Homepage: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015