Notes

FDA's Most Dangerous Recalls in 2022 - Incorrect Feeding Tubes Ahead (Avanos Medical)
Avanos Medical Cortrak2 feeding tubes are the most deadly medical devices as per FDA recalls.

While 2022 is not yet over, FDA already has 50 medical devices listed on its recall list. The recall has led to the tragic deaths of 36 and the injury of 224. Avanos Medical ranks number one on the 2022 medical device malfunctions list with 23 deaths attributed to an improperly placed feeding tube.


These are the four most dangerous medical device malfunctions in accordance with the FDA recall notice.

Avanos Mediacal Cortrak 2 Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
The misplacement of the nasogastric feed tube caused 60 injuries and 23 fatalities.

Avanos Medical This is the most common reason for death in recalled devices.


Avanos Medical has recalled the Cortrak*2 Enteral Access System due to reports of injuries and patient deaths following nasoenteric or Nasogastric feeding tubes have been placed incorrectly.


If a nasogastric, or Nasoenteric, tubes are improperly installed, patients could be injured to their vocal cords, lungs, or the trachea. This could result in serious injury , and possibly death. To protect themselves, Avanos Medical sent warning to doctors, suggesting that the hospital or user "...confirm the placement of the NG/NI tube according to hospital procedure" Fox news reported.

https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos Medical's recall communication reported that the CORTRAK*2 Ental Access System has been misplaced by enteral tube feeding since the year 2015.

Avanos Mediacal Cortrak 2 Baxter recalls SIGMA Spectrum Infusion Pumps that have Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter received 51 reports of serious injury and three reports on patients' deaths over the last five years.

The medical device manufacturer Baxter has recalled the device after numerous complaints of a security alarm malfunction. The alarm on the pumps was not able to be activated in the case of upstream occlusion events. These products could cause negative health effects that can cause death as per the announcement.

Avanos Medical feeding tube Medtronic recalls EMG reinforced Endotracheal Tube
There have been three accidents and 2 deaths attributed with the use of this device.

Two deaths and three injuries resulted from the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endeotracheal Tube that serve to monitor the head and laryngeal nerves. The company isn't asking customers to return or replace the affected devices , but it has sent out safety notices to ensure that the device's silicon cuff from blocking a patient's airway.


Avanos Mediacal Cortrak 2 If the tube is unable to adequately ventilate or block the airway, patients could suffer from deprivation of oxygen, brain damage, or death.

Cortrak 2 eternal access system Baxter Healthcare Corporation Recalls Volara System
This device has been associated with one injury and two deaths.

Baxter Healthcare Corporation, and Hillrom the subsidiary company, are recalling the Volara Systems. This is because the adaptor for inline ventilators may not allow patients using at-home devices to receive sufficient oxygen. There are some risks for those affected, including choking on mucus and airway secretions, lung infection (pneumonia) which blocks oxygen from reaching the bloodstream (respiratory failure) as well as brain injury because of a lack of oxygen (hypoxia), as well as death.


This list contains human life 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 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 HeartWare HVAD System Batteries

Injuries: 6

Deaths: 1

Philips Respironics recalls all V60 and V60 Plus ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump 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. 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 Stents that are covered

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 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


Website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/