Notes

The FDA's most deadly recalls for 2022 - Misplaced Feeding Tubes Leading (Avanos Medical)
Based on FDA recalls The Avanos medical Cortrak2 feeding tube is the most dangerous medical device.

2022 hasn't yet come to an end, yet the FDA's list for recalls of medical devices has already reached 50. The result of the recalls to date is unfortunate, with 36 deaths and 224 injuries. Avanos Medical is first on the list for 2022 regarding malfunctions in medical devices, with 23 reported deaths due to feeding tubes that were not properly placed.


These are the 4 deadliest medical device malfunctions according to the FDA medical device recall notice:

Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
The misplacement of nasogastric feeding tubes resulted in the deaths of 23 and injuries to 60.

In 2022 , this device malfunction was the most significant cause of death for all affected medical equipment.


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service because of accidents and deaths that result from inadvertently placing nasogastric feed tubes.


Avanos Medical feeding tube If a nasogastric or nasoenteric, tube is incorrectly placed, patients could be injured to their vocal cords, lungs, or trachea. This can cause serious injuries and even death. Avanos Medical issued a announcement to the healthcare providers to confirm the positioning of the NG/NI tubing according to institution guidelines. Fox news reported.

Avanos Medical's recall notification disclosed the deaths 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 Pumps equipped with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received 51 complaints of serious injuries as well as three cases of deaths over the course of five years, which could be linked with this issue.

The medical device maker Baxter recalled this device after numerous complaints of a malfunctioning safety alarm. Cortrak 2 eternal access system The alarms on the pumps were not activated in the event of an upstream obstruction. Avanos Medical These substances can have adverse health consequences that could result in death according to the announcement.

Medtronic Recalls the NIMCACT Reinforced Endotracheal Tube EMG
The use of the device resulted in 3 injuries as well as 2 deaths.

Three injuries and two deaths were caused by the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube that are used to track the head and laryngeal nerves. Avanos Medical feeding tube Although the company doesn't require customers to return the defective devices or replace them, they sent security alerts to ensure the silicone cuff did not restrict a patient's airway.


Patients are at risk of suffering from oxygen deprivation, brain damage or death in the event that the tube isn't ventilating effectively or block the airway.

Baxter Healthcare Corporation Recalls Volara System
There was one injury and 2 deaths associated with the use of this device.

Baxter Healthcare Corporation is recalling its Volara system subsidiary, Hillrom. The adaptor connected to ventilators may prevent home-use patients getting enough oxygen. The most vulnerable patients are people who breathe mucus, respiratory failure (pneumonia) or brain injury (hypoxia), and choking.


This is a list 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 (Version 8) & Spectrum IQ Infusion Systems (Version 9) the occlusions

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 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 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. Cortrak 2 eternal access system Recalls HawkOne Directional Atherectomy System

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, a Stent that is covered by the iCa

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

Avanos Medical feeding tube
Homepage: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding