Notes

FDA's Deadliest Recalls 2022: Misplaced Feeding Tubes Ahead (Avanos Medical)
According to FDA recalls, Avanos ' Medical Cortrak2 is the most hazardous medical device.

Although 2022 is still not completed, the FDA has already prepared the following list of recalls of medical devices. These recalls have resulted in 36 deaths and 228 injuries. Avanos Medical ranks first on the 2022 list of medical device failures with 23 deaths reported by misplaced feeding tubes.


These are the top four serious malfunctions in medical devices, according to the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently removing nasogastric feeding tube tubes resulted in 60 injuries and 23 deaths.

This is the most common cause of death among recalled devices.


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


Patients may suffer serious injuries or even death if the nasogastric tub or nasoenteric tube is wrongly inserted. Avanos Medical notified that users "...as well as hospitals should verify the positioning of the N/NI tubes as per the guidelines of the institution. Cortrak 2 eternal access system Fox News said.

Avanos Medical reported in a recall notice that the deaths and injuries caused by misplacement or use of feed tubes to the stomach while using the CORTRAK*2 Ental Access System.

Baxter recalls SIGMA Spectrum Infusion pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received reports about serious injuries and three deaths of patients that could be related to this issue over the past five years.

Following numerous complaints about malfunctioning safety alarms, the manufacturer of medical devices Baxter has issued a recall on the device. The alarms on the pumps were not triggering in the case of upstream occlusion events. These chemicals can trigger adverse health effects that can cause death according to the announcement.

Medtronic Recalls NIM Contact Reinforced Endotracheal Tube with EMG
The device has been linked to 3 deaths and 2 injuries.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube These tubes are utilized to create an airway and to monitor the laryngeal nerves undergoing head and neck surgery - are the source of three injuries and two deaths before Medtronic's recall. The company hasn't asked customers to return or swap the affected devices but they have issued safety announcements to ensure that the device's silicon cuff from obstructing a patient's airway.


https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ Avanos Medical Patients may suffer from brain damage, oxygen deprivation or death if the tube doesn't ventilate well or blocks the airway.

https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events Baxter Healthcare Corporation Recalls Volara System
The use of this device lead to 2 injuries, and 1 deaths.

Baxter Healthcare Corporation, and Hillrom, its subsidiary company, are recalling the Volara Systems. Cortrak 2 eternal access system This is because the adaptor that is used to connect in-line ventilators may not allow home-use patients to get enough oxygen. Avanos Medical Patients at risk include people who breathe mucus respiratory failure (pneumonia), brain injuries (hypoxia) and choking.


Avanos Medical This is a list of human life-saving costs in 2022 for medical device malfunction or misuse:


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

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

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

Injuries: 7

Deaths: 1

Medtronic recalls 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 the HeartWare HVAD Systems Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Medtronic Inc.

Cortrak 2 eternal access system 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 Stent Covered

Injuries: 9

Deaths: 0

Vyaire Medical recalls bellavista 1000 Series 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://www.pulmccm.org/p/fda-warns-of-pneumothorax-death-associated-with-high-tech-nasogastric-tubes