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FDA's Most Dangerous Recalls in 2022 - Misplaced Feeding Tubes The most feared (Avanos Medical)
Based on FDA recalls, the Avanos Medical Cortrak2 feeding tube is the most deadly medical device.

2022 isn't even close to an end, yet the list of FDA-approved recalls for medical devices has already reached 50. This recall has caused the unfortunate deaths of 36 and more than 224 injuries. Avanos Medical is first on the 2022 list for malfunctions with medical devices, with 23 reports of deaths due to faulty feeding tubes.


These are the top four grave medical device malfunctions 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.

It is the most frequently reported cause of death among recalls of devices.


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


In cases where a nasogastric or nasoenteric tubing is placed incorrectly, patients could experience harm to their vocal cords, lungs or trachea, all of which could cause serious harm or death. Avanos Medical issued a notice to doctors and other healthcare professionals to verify the placement of the NG/NI tubes in accordance with institutional protocol. Fox news announced.

Avanos Medical reported in a recall notification that injuries and deaths were resulted from the incorrect placement or misuse of the feed tubes to the stomach while employing the CORTRAK*2 Ental Access Systems.

Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) & Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries. Cortrak 2 eternal access system There were three deaths reported by patients over the course of five years, which could be linked with this issue.

Following numerous complaints about safety alarms malfunctioning after numerous complaints of safety alarm malfunctions, the medical device maker Baxter has recalled this device. The alarm on the pumps failed to sound in the event of upstream occlusion events. A warning was issued that these products could have adverse health consequences and may even lead to death.

Avanos Medical feeding tube Medtronic recalls EMG reinforced Endotracheal Tube
There have been three incidents of injury and two deaths to the use of this device.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube Both utilized to help provide airway and monitor laryngeal nervous systems during head and neck surgery was responsible for three fatalities and two injuries prior to Medtronic's recall. Although the company doesn't ask customers to return the defective devices or replace them, they sent warnings about safety to make sure that the cuff's silicone material didn't restrict a patient's airway.


If the tube fails to vent properly or block the airway, patients might be afflicted with oxygen deprivation or brain damage. This could lead to death.

Avanos Medical feeding tube Baxter Healthcare Corporation Recalls Volara System
The use of this device lead to one injury and two deaths.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor that connects to ventilators in line could stop patients at-home from getting sufficient oxygen. The risks to affected patients include choking on mucus or other airway secretions, lung infection (pneumonia) which prevents oxygen from reaching the blood (respiratory failure), brain injury resulted from a lack of oxygenation to the brain (hypoxia) and death.


This is a listing of the human lives lost due to the misuse of medical devices or their malfunction in 2022.


https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its Avanos Medical Recalls Cortrak*2 Enteral 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 that has 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 Recalls Certain Medfusion 3500 and 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HeartWare HVAD system batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic recalls 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. Cortrak 2 eternal access system Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC which is a subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stents that are covered

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 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://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/