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FDA'S DEADLIEST RECALLS 2022 – UNPLACED FEEDING TUBES INSPIRING (AVANOS MEDICAL)

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According to FDA recalls The Avanos medical Cortrak2 feeding tube is the top
deadliest medical device.

While 2022 isn't finished but the FDA has already prepared the list of 50
recalls for medical devices. The recalls have resulted in 36 deaths and 228
injuries. Avanos Medical ranks number one on the 2022 list of malfunctions in
medical devices with 23 deaths related to unintentionally placed feeding tubes.


The four most deadly medical device malfunctions according to the FDA medical
device recall notification:

Avanos Medical Remands Cortrak*2 Enal Access System for Feeding Tubs
Inadvertently, removing nasogastric feeding tubes has resulted in 60 injuries as
well as 23 deaths.

The malfunction of this device is the leading cause of death for all medical
devices that are recalled by the FDA in 2022..


Avanos Medical has pulled the Cortrak*2 Enteral Access System from service due
to death and injuries resulting from inadvertently placing nasogastric feed
tubes.


Patients could be seriously injured or even death if a nasogastric tube or
nasoenteric tub has been improperly placed. Avanos Medical notified that
patients "...as well as hospitals must verify the placement of the N/NI tubes as
per institution protocol. Fox News reported.

Avanos Medical feeding tube Avanos Medical's recall notifications stated that
the CORTRAK*2 Accessory System has been missing enteral feeding tubes since
2015.

Baxter recalls SIGMA Spectrum Infusion pumps equipped with Master Drug Library
(Version 8) and Spectrum IQ Infusion Systems With Dose IQ Safety (Version 9)
Baxter has received 51 complaints of serious injuries, and three reports of
patient deaths in the past five years that could be associated with this issue.

Baxter, a producer of medical devices has announced a recall of the device due
to reports of a failure in the safety alarm. The alarms on the pumps were not
being activated in case of occlusions in the upstream. The announcement warned
that use of these products can cause adverse health effects, which could lead to
death.

Medtronic Recalls NIMCACT Reforced Endotracheal Tube EMG
There have been three accidents and 2 deaths attributed with the use of this
device.

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard
Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG
Endotracheal Tube - both used to help provide airway as well as monitor
laryngeal nerves undergoing head and neck surgery - have been responsible for
three injuries and two deaths before Medtronic's recall. Although the company
doesn't require customers to return defective devices or exchange the devices,
they did send out safety notices to ensure that the silicone cuff did not impair
a patient's airway.


If the tube doesn't ventilate properly or obstructs the airway, patients might
be suffering from oxygen deprivation, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System
The device has been linked with 1 injury and 2 deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling
the Volara System due to the fact that the inline ventilator adaptor could
hinder home-based patients from receiving enough oxygen from their ventilators.
Avanos Medical Avanos Medical The risk for patients affected include choking on
mucus or other airway mucus, lung infections (pneumonia) that blocks oxygen from
getting to the blood (respiratory failure), brain injury caused by a lack in
oxygenation to the brain (hypoxia), and death.


Cortrak 2 eternal access system This list contains the human lives lost because
of medical device misuse or malfunction in 2022.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version
8) and Spectrum IQ Infusion Systems With Dose IQ Safety Software(Version 9) the
occlusions

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 HeartWare HVAD System Batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic recalls 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. Recalls HawkOne Directional Atherectomy System

Injuries: 55

Deaths: 0

Arrow International, LLC (Subsidiary of Teleflex Inc.) Avanos Medical Cortrak 2
eternal access system Recalls the Arrow-Trerotola percutaneous thrombolytic
Device

Injuries: 14

Deaths: 0

Atrium Medical Corporation Recalls iCast Stents 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 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

https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/


Public Last updated: 2022-12-04 01:07:06 PM

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