Notes

FDA's Most Dangerous Recalls in 2022 - Food Feeding Tubes Ahead (Avanos Medical)
According to FDA recalls, Avanos ' Medical Cortrak2 is among the most dangerous medical device.

While 2022 is not yet completed, FDA already has 50 medical devices on its recall list. This recall has caused an unfortunate 36 deaths, and 228 injuries. Avanos Medical is first on the list of 2022 malfunctions of medical devices, and has 23 deaths attributed to the wrong placement of feeding tubes.


The four most deadly medical device malfunctions as per the FDA medical device recall notice:

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

This is the leading reason for death in recalled devices.


Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and patient death after nasoenteric feeding tubes were improperly placed.


If a nasogastric, also known as a Nasoenteric, tubes are improperly put in the wrong place, patients can suffer damage to the vocal cords, their lungs or trachea. This could result in serious injuries and even death. https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system As a precautionary measure, Avanos Medical sent an alert to healthcare providers asking the patient or the hospital "...confirm the placement of the NG/NI tubes in accordance with hospital procedure" Fox news reported.

Avanos Medical reported in a recall communication that fatalities and injuries were caused by the improper placement or improper use of an feed tubes to the stomach while employing the CORTRAK*2 Ental Access Systems.

Baxter recalls SIGMA Spectrum Infusion pumps with 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 over the course of five years, which could be linked with this issue.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Baxter, a producer of medical devices has announced a recall of the device in response to numerous reports of a malfunctioning safety alarm. Avanos Mediacal Cortrak 2 The alarm on the pumps failed to sound in the event of occlusions in the upstream. feeding tube placement feeding tube placement The announcement warned that use of these affected products may cause adverse health consequences, including death.

https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A Medtronic Recalls EMG Reinforced Endotracheal Tube
There have been three injuries and 2 deaths that have been linked with the use of the device.

The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube both designed to improve airway flow and monitoring of the laryngeal nervous system during head and neck surgery caused two deaths and three injuries before Medtronic's recall. The company doesn't want clients to replace or return the affected devices , but it has they have issued safety announcements to keep the device's cuff from blocking an individual's airway.


Patients could suffer from oxygen deprivation, brain injury or even death , if the tube isn't ventilated correctly.

feeding tube placement Baxter Healthcare Corporation Recalls Volara System
This device has been associated with 2 accidents and one injury. deaths.

Baxter Healthcare Corporation, and Hillrom the subsidiary company, are recalling the Volara Systems. Avanos Mediacal Cortrak 2 This is due to the fact that the adaptor used for in-line ventilators might not permit home-use patients to get enough oxygen. Patients at risk include breathing in mucus, respiratory failure (pneumonia) or brain injuries (hypoxia), and coughing.


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


Avanos Medical Recalls Cortrak*2 Ental Access System

Injuries: 60

Deaths: 23

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

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced Endotracheal Tube as well as 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 the HVAD Systems HeartWare 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. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC as a Subsidiary of Teleflex Inc., recalls the Arrow-Trerotola PercutaneousThrombolytic Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls the iCast Stent, which is covered by iCas

Injuries: 9

Deaths: 0

Vyaire Medical Recalls Bellavista 1000 Series 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


Read More: https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A