Notes

Deadliest FDA Recalls 2022 - Missing Feeding Tubes Leading (Avanos Medical)
As per FDA recalls, the Avanos Medical Cortrak2 is among the most hazardous medical device.

2022 isn't even close to an end, yet the list of recalls by the FDA for medical devices stands at 50. The recall has led to the unfortunate deaths of 36 and 228 injuries. Avanos Medical ranks first on the list of 2022 malfunctions of medical devices, with 23 reports of deaths caused by misplaced feeding tubes.


These are the four most serious medical device malfunctions, in accordance with 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.

Avanos Medical feeding tube Avanos Medical This malfunctioning device is the most significant reason for death among all medical devices that are recalled by the FDA in 2022.


Avanos Medical feeding tube Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injuries and deaths among patients who had nasogastric or nasoenteric feeding tubes that were improperly placed.


Patients could be seriously injured or even death if the nasogastric tube or nasoenteric tub has been wrongly placed. Avanos Medical notified that users "...as well as hospitals must verify the placement of N/NI tubes according to institutional guidelines. Fox News said.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Avanos Medical's recall notification reported the injuries and deaths related to the misplacement of the feed tubes to the stomach when using the CORTRAK* 2 Enteral Access System from 2015.

Avanos Medical 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, and three deaths of patients which could be linked to this issue in the last five years.

Baxter, a company that makes medical devices has announced a recall of the device due to reports of a safety alarm failure. In the event of an obstruction upstream the alarm was unable to start the pumps. The announcement warned that the use of these affected products may cause negative health effects, such as death.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
The device has been linked to 3 injuries and 2 fatalities.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Two deaths and three injuries resulted from the NIMCONTACT Reinforced EMG Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube that serve to monitor the head and laryngeal nerves. Medtronic isn't asking its customers to return or replace the affected devices , but it has issued safety warnings to stop the device's silicone cuff from obstructing a patient's airway.


Patients can experience an oxygen deficiency, brain injury or even death if the tube is not properly ventilated.

Baxter Healthcare Corporation Recalls Volara System
The application of this device led to 2 injuries, and 1 deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System due to the fact that the inline ventilator adapter could prevent patients who use home care in getting enough oxygen from their ventilators. There are some risks for those affected that include choking on mucus or other airway fluids and lung infection (pneumonia) that prevents oxygen from reaching the blood (respiratory Failure) and brain injuries because of a lack of oxygen (hypoxia) along with death.


This is the list of human deaths in 2022 due medical device malfunctions or abuse.


Avanos Medical Recalls Cortrak*2 Ental 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) 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 Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps

Injuries: 7

Deaths: 1

Medtronic recalls the HeartWare HVAD Systems Batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus 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. Avanos Mediacal Cortrak 2 Recall of the HawkOne Directional Atherectomy Systems

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stent Covered

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista1000e Series Ventilators

Injuries: 7

Deaths: 0

LivaNova (TandemLife) Recalls LifeSPARC System

Injuries: 2

Deaths: 0

Draeger, Inc recalls SafeStar 55 Breathing Systems 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://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/