Notes

FDA's Deadliest Recalls in 2022 Incorrect Feeding Tubes Ahead (Avanos Medical)
According to FDA recalls, the Avanos Medical Cortrak2 feeding tube is the most deadly medical device.

While 2022 isn't completed The FDA has already put together an inventory of 50 recalls of medical devices. Avanos Medical This recall has caused 36 deaths and 228 injuries. https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/ Avanos Medical is first on the 2022 list for malfunctions with medical devices, with 23 reported deaths due to faulty feeding tubes.


Avanos Medical The following are the top four hazardous medical device errors, according to the FDA recall notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently taking out nasogastric tube feeding tubes caused 60 injuries and 23 deaths.

In 2022 the year 2022, the malfunction of this device was the main reason for death among all affected medical equipment.


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


Patients may suffer serious injuries or even death, if a nasal tube or nasoenteric tub is incorrectly inserted. Avanos Medical notified that users "...and hospitals should verify the positioning of N/NI tubes as per hospital protocol. Fox News said.

https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges Avanos Medical's recall notifications stated that the CORTRAK*2 Enteral Access System was misplaced in enteral feeding tubes since 2015.

Baxter recalls SIGMA Spectrum Infusion Pumps that have Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter received 51 reports of serious injury and three reports on patient deaths in the past five years.

After numerous complaints of safety alarms malfunctioning The medical device manufacturer Baxter has decided to recall this device. In the event of an obstruction in the upstream the alarm was unable to activate on the pumps. https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns The announcement warned that the use of the affected products could cause adverse health consequences, including death.

Medtronic Recalls NIM Contact Reinforced Endotracheal Tube with EMG
There have been three accidents and 2 deaths attributed with the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to open an airway as well as monitor laryngeal nerves during head and neck surgeries - have been responsible for three injuries and two deaths ahead of Medtronic's recall. Avanos Mediacal Cortrak 2 Although the company hasn't asked customers to return defective devices or replace the devices, they did send out warnings about safety to make sure that the cuff made of silicone didn't hinder a patient's breathing.


Patients may experience an oxygen deficiency, brain injury, or even death if the tube is not ventilated appropriately.

Baxter Healthcare Corporation Recalls Volara System
There has been 1 injury and 2 deaths associated by the use of this device.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System because the in-line ventilator adaptor could hinder home-based patients from receiving enough oxygen from their ventilators. Patients who are affected are choking on mucus, or other airway fluids, lung infections (pneumonia) which prevents oxygen from reaching the bloodstream (respiratory failure), brain injury due to a lack of oxygenation to the brain (hypoxia), and death.


This is a listing of people's lives that were lost because of medical device failure or misuse in 2022.


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) and Spectrum IQ Infusion Systems With Dose IQ Safety Software(Version 9) 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 Remands Certain Medfusion 3500 & 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 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 of Teleflex Inc.) Recalls the Arrow-Trerotola percutaneous thrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls ICast, a Stent that is covered by the iCa

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 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


Website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/