Notes

FDA's Most Dangerous Recalls in 2022 - Unplaced Feeding Tubes Ahead (Avanos Medical)
As per FDA recalls, Avanos ' Medical Cortrak2 is the most hazardous medical device.

While 2022 isn't yet over but the FDA has already created an inventory of 50 recalls of medical devices. The recalls have caused 36 deaths and 228 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions , with 23 deaths reported by misplaced feeding tubes.


They are the 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 led to 60 injuries and 23 fatalities.

It is the most frequently reported cause of death among recalls of devices.


Avanos Medical has recall the Cortrak*2 Enteral Access System after reports of injury and death in patients who received nasogastric or nasoenteric feeding tubes that were incorrectly placed.


In the event that a nasogastric or nasoenteric tubes is inserted incorrectly, patients could experience injuries to the vocal cords, lungs or trachea. All of which could result in serious injury or death. Avanos Medical As a precaution, Avanos Medical sent notice to providers and suggested that the hospital or user "...confirm the placement of the NG/NI tubes per hospital protocol" Fox news reported.

Avanos Medical reported in a recall announcement that fatalities and injuries were caused by the misplacement or the use of an food tube for enteral use while employing the CORTRAK*2 Ental Access Systems.

https://www.transtats.bts.gov/exit.asp?url=https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/ 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 received 51 cases of serious injury and three reports of patient deaths within the last five years.

Baxter, a producer of medical devices , has recalled the device due to reports of a malfunctioning safety alarm. The alarms on the pumps was failing to trigger in the event of upstream occlusion events. Avanos Mediacal Cortrak 2 feeding tube placement These chemicals can trigger adverse health consequences that could cause death according to the announcement.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube
There have been 3 injuries and 2 deaths that have been linked with the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube as well as the NIM Standard Reinforced EMG Endotracheal Tube These tubes are used to provide an airway and to monitor the laryngeal nerves during head or neck surgeries - were the source of three injuries and two deaths ahead of Medtronic's recall. Although Medtronic isn't asking for customers to replace damaged devices, it has released safety announcements in order to prevent the cuff made of silicone to block a patient's airway.


If the tube fails to ventilate properly or obstructs the airway, patients might be afflicted with oxygen deprivation and brain damage or death.

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

Avanos Mediacal Cortrak 2 Baxter Healthcare Corporation, and Hillrom its subsidiary company are recalling the Volara Systems. The reason for this is that the adaptor for inline ventilators might not permit home-use patients to get enough oxygen. The risk for patients affected include choking on mucus or other airway secretions lung infections (pneumonia) that blocks oxygen from getting to the bloodstream (respiratory failure) as well as brain injury caused by lack of oxygenation to the brain (hypoxia) and even death.


Avanos Medical feeding tube This is a list of the human lives lost due to the misuse of medical devices or their malfunction 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 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 and 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 the heartWare's batteries HVAD system.

Injuries: 0

Deaths: 1

Covidien, LP Recalls Puritan Bennett 980 Series Ventilator

Injuries: 0

Deaths: 1

Medtronic Inc. Recall of HawkOne Directional Atherectomy Systems

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-Covered Stent

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 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


Website: https://bbs.pku.edu.cn/v2/jump-to.php?url=https://www.massdevice.com/avanos-medical-recall-of-cortrak-2-enteral-access-system-is-class-i/