Notes

Deadliest FDA Recalls 2022. Misplaced Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most dangerous medical devices, as per FDA recalls.

The year 2022 hasn't come to an end, and the FDA's list of recalled medical devices is currently at 50. This recall has caused 36 deaths and 228 injuries. Avanos Medical ranks number one on the 2022 list of medical device malfunctions with 23 reported deaths from the wrong placement of the feeding tube.


The following are the top four hazardous medical device errors, in accordance with the FDA recall notification:

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes
Inadvertently removing nasogastric feeding tube tubes has resulted in 60 injuries as well as 23 deaths.

In 2022 the year 2022, the malfunction of this device was the most significant cause of death in all recalled medical equipment.


Avanos Medical feeding tube Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and deaths resulting from nasoenteric and nasogastric feeding tubes were put in the wrong place.


In instances where a nasal or nasoenteric tubing is placed in a way that is not correct, patients can suffer injuries to the vocal cords, lungs or trachea, all of which can lead to serious harm or death. As a precautionary measure, Avanos Medical sent the notice to healthcare professionals, suggesting that the patient or the hospital "...confirm the location of the NG/NI tubes per institution procedure" Fox news reported.

Avanos Medical's recall notifications stated that the CORTRAK*2 Enteral Access System has been misplaced by enteral feeding tubes since 2015.

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)
Baxter has received 51 reports about serious injuries and three reports regarding patient deaths which could be linked to this issue over the past five years.

https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical After numerous complaints of safety alarm malfunctions The medical device manufacturer Baxter has announced a recall of this device. The alarms on the pumps weren't being activated in case of occlusions in the upstream. These chemicals can trigger adverse health effects that could result in death in the event of a fatality, as stated in the announcement.

Avanos Medical feeding tube Medtronic Recalls EMG Reinforced Endotracheal Tube
This device has been linked to 3 injuries and 2 fatalities.

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - both used to provide an airway and monitor laryngeal nerves in head and neck surgeries - have been the cause of three injuries and two deaths ahead of Medtronic's recall. While Medtronic hasn't asked customers to return defective devices, the company released safety announcements in an effort to stop the cuff made of silicone in the patient's airway.


Avanos Mediacal Cortrak 2 Patients can experience the deprivation of oxygen, brain injuries or even die if the tube is not ventilated properly.

Baxter Healthcare Corporation Recalls Volara System
There have been one death and 1 injury by the use of this device.

Avanos Mediacal Cortrak 2 Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the inline ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risk for patients affected include choking on mucus or other airway secretions lung infection (pneumonia) that prevents oxygen from reaching the blood (respiratory failure), brain injury caused by lack of oxygen to the brain (hypoxia) and even death.


This list contains the human lives lost because of medical device malfunction or misuse in 2022.


Avanos Medical Recalls Cortrak*2 Ental 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) the occlusion event

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 ventilatilators

Injuries: 4

Deaths: 1

Medtronic recalls HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls batteries of the HeartWare HVAD system

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recall of the HawkOne Directional Atherectomy Systems

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 Covered Stent

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 the SafeStar55 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


Website: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges