Notes

The FDA's most dangerous recalls of 2022 The Misplaced Feeding Tubes The most feared (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are the most dangerous medical devices, as per FDA recalls.

While 2022 isn't completed even though 2022 isn't over yet, the FDA has already compiled the list of 50 recalls for medical devices. This recall has resulted in the unfortunate deaths of 36 and more than 224 injuries. Avanos Medical is first on the list of 2022 for malfunctions of medical devices, and has 23 deaths attributed to feeding tubes that were not properly placed.


They are the deadliest medical device malfunctions , according to the FDA medical device recall Notice:

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Misplacement of nasogastric feed tubes resulted in 60 injuries, and 23 deaths.

In 2022 the year 2022, the malfunction of this device was the primary cause of death for all recalls of medical equipment.


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


Avanos Medical feeding tube Patients are at risk of serious injury or even death if the nasogastric tub or nasoenteric tube is incorrectly inserted. Avanos Medical issued a notification to requesting that providers confirm the positioning of the NG/NI tube per hospital guidelines. Fox news covered the story.

Avanos Medical's recall communications included the fatalities and injuries related to the misplacement of the tubes feeding into the enteral lining when using the CORTRAK* 2 Enteral Access System from 2015.

Baxter recalls SIGMA Spectrum Infusion Systems, which includes Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries, and three cases of deaths in the past five years that could be associated with this problem.

The medical device manufacturer Baxter has recalled the device following numerous reports of a malfunctioning safety alarm. Avanos Mediacal Cortrak 2 Alarms on the pumps were not activated in the event of an upstream obstruction. The announcement warned users that using these affected products could result in adverse health effects, which could lead to death.

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

Avanos Medical Two deaths and three injuries were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube which are used to monitor the head and laryngeal nerves. Although the company doesn't ask customers to return the defective devices or to replace them, it sent out safety notices to ensure that the cuff made of silicone didn't block a patient's airway.


Patients can suffer from an oxygen deficiency, brain injury, or even die if the tube is not ventilated properly.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has led to 2 injuries and 2 deaths.

Baxter Healthcare Corporation, and Hillrom the subsidiary company, have recalled the Volara Systems. The reason for this is that the adaptor used for in-line ventilators might not permit patients with home use to get enough oxygen. https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its There are risks for patients affected such as choking on mucus and airway secretions, lung infection (pneumonia) that blocks oxygen from getting into the bloodstream (respiratory Failure) and brain injuries caused by a lack of oxygen (hypoxia) and as well as death.


This list contains the human lives lost due to medical device malfunction or misuse in 2022.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

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

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube

Injuries: 3

Deaths: 2

Baxter Healthcare Corporation Recalls Volara System

Injuries: 1

Deaths: 2

Smiths Medical Remands Certain Medfusion 3500 and 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic recalls HVAD HeartWare system batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus ventilatilators

Injuries: 4

Deaths: 1

Medtronic recalls the HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic Recalls the HVAD Systems HeartWare Batteries

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Avanos Medical feeding tube Medtronic Inc.

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast covered sten

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista1000 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


Here's my website: https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its