Notes

FDA's Most Dangerous Recalls in 2022 - Misplaced Feeding Tubes Inspiring (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are among the most hazardous medical devices as per FDA recalls.

Avanos Medical feeding tube Although 2022 isn't yet over, FDA already has 50 medical devices listed on the recall list. The recall has led to the unfortunate deaths of 36 and 224 injuries. Avanos Medical is first on the list of 2022 for malfunctions with medical devices, with 23 reported deaths due to misplaced feeding tubes.


These are the four deadliest medical device malfunctions , according to the FDA medical device recall Notice:

Avanos Medical Remands Cortrak*2 Enal Access System for Tubs that Feed
Incorrect placement of nasogastric feed tubes caused 60 injuries and 23 deaths.

Avanos Medical In 2022 in 2022, this device malfunction was the most significant cause of death for all recalled medical equipment.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of deaths and injuries among patients who had nasogastric or nasoenteric feeding tubes that were not correctly placed.


If a nasal nasogastric Nasoenteric, tubes are improperly placed, patients may be injured to their vocal cords, lungs, or trachea. It could result in severe injury and even death. Avanos Medical issued a note to patients requesting that they verify the location of the NG/NI tubing according to institutional protocol. Fox news published an article about the issue.

Avanos Medical's recall communication reported that the CORTRAK*2 Accessory System has been missing enteral feeding tubes since the year 2015.

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 calls regarding serious injuries as well as three reports regarding patient deaths possibly related to this issue in the past five years.

Avanos Medical feeding tube The medical device manufacturer Baxter Recalled this device after numerous complaints of a malfunctioning safety alarm. The alarms on the pumps failed to trigger in the event of upstream occlusions. The announcement warned that use of these affected products may cause adverse health consequences, including death.

Cortrak 2 eternal access system Medtronic Recalls the NIMCACT Reinforced EMG Endotracheal Tub
This device has been associated with three injuries and two deaths.

Avanos Medical The NIMCONTACT Reinforced EMG Tube and the NIM Standard Reinforced EMG Tube both designed to improve airway flow and monitor laryngeal nervous systems during neck and head surgeries - were responsible for three deaths and three injuries prior to Medtronic's recall. Although the company doesn't require clients to return their defective devices or exchange the devices, they did send out safety notices to ensure that the cuff's silicone material didn't impair a patient's airway.


Patients may experience oxygen deprivation, brain injury, or even death , if the tube isn't ventilated correctly.

Baxter Healthcare Corporation Recalls Volara System
The usage of this device has led to 2 injuries and 2 deaths.

Cortrak 2 eternal access system Baxter Healthcare Corporation, and Hillrom the subsidiary company, are recalling its Volara Systems. The reason for this is that the adaptor for inline ventilators might not permit patients using at-home devices to receive sufficient oxygen. There are risks for patients affected such as choking on mucus and other airway secretions and lung infection (pneumonia) that blocks oxygen from reaching the bloodstream (respiratory failure) and brain injuries because of a lack of oxygen (hypoxia) and as well as death.


This is the list of deaths of humans in 2022 due to the malfunction of medical devices or their misuse.


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) Occlusion events

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 Remands Certain Medfusion 3500 and 4000 Syringe Pumps

Injuries: 7

Deaths: 1

Medtronic recalls HVAD HeartWare system 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 batteries of the HeartWare HVAD system.

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Medtronic Inc.

Injuries: 55

Deaths: 0

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

Injuries: 14

Deaths: 0

Atrium Medical Corporation recalls iCast covered sten

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista 1000 and 1000e 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.nutritioncare.org/News/General_News/Nasoenteric_Feeding_Tube_Placement_and_Verification/