Notes

FDA's Deadliest Recalls 2022 – Unplaced Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most lethal medical devices as per FDA recalls.

Although 2022 isn't yet over, FDA already has 50 medical devices listed on its recall list. This recall resulted in the tragic deaths of 36 and 228 injuries. Avanos Medical ranks number one on the 2022 list of medical device malfunctions with 23 deaths attributed to unintentionally placed feeding tubes.


These are the most dangerous medical device safety errors, in accordance with the FDA recall notification:

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

This device malfunction is the main reason for death among all medical devices that are recalled by the FDA in 2022..


https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due to accidents and deaths that result from improper placement of nasogastric feeding tubes.


Patients are at risk of serious injury or death if a nasogastric tube or nasoenteric tub has been wrongly placed. Avanos Medical In order to protect themselves, Avanos Medical sent notice to providers, suggesting that the patient or the hospital "...confirm the location of the NG/NI tubes in accordance with institutional protocols" Fox news reported.

Avanos Medical reported in a recall notice that fatalities and injuries were caused by the misplacement or misuse of the tubes for feeding into the enteral system when using the CORTRAK*2 Ental Access System.

Avanos Medical feeding tube Baxter recalls SIGMA Spectrum Infusion pumps that have Master Drug Library (Version 8) & Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received 51 complaints of serious injuries as well as three cases of deaths over five years potentially associated with this issue.

The medical device manufacturer Baxter recalled this device following numerous reports of a malfunctioning safety alarm. In the event of an obstruction to the flow of the water the alarm did not trigger on the pumps. Avanos Medical feeding tube The warnings were issued that these products could cause adverse health consequences and may even lead to death.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
The device's use led to 3 injuries, and two deaths.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - which are used to open an airway as well as monitor laryngeal nerves during head and neck surgeries - were the cause of three injuries and two deaths prior to Medtronic's recall. The company doesn't want customers to return or swap the devices affected, but has sent out safety notices to keep the device's cuff from blocking an individual's airway.


Avanos Medical Patients can be affected by the lack of oxygen, brain damage or even death when the tube does not ventilate well or block airways.

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

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor that connects to ventilators in line could stop patients using the home ventilator from receiving enough oxygen. Patients at risk include those who breath in mucus respiratory failure (pneumonia), brain injury (hypoxia), and breathing difficulties.


This list contains human life lost because of the misuse of medical devices or their malfunction in 2022.


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps (Version 8) & Spectrum IQ Infusion Systems (Version 9) obstructions

Injuries: 51

Deaths: 3

Medtronic Recalls NIM CONTACT Reinforced EMG 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 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. Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Thrombolytic Percutaneous 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 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.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its