Notes

Deadliest FDA Recalls 2022. Misplaced Feeding Tubes The most feared (Avanos Medical)
Based on FDA recalls The Avanos medical Cortrak2 feeding tube is the most dangerous medical device.

The year 2022 hasn't come to an end yet, however the list of FDA-approved recalls for medical devices is already at 50. This recall has resulted in an unfortunate 36 deaths, and more than 224 injuries. Avanos Medical is first on the list for 2022 regarding medical device malfunctions, with 23 reports of deaths due to faulty feeding tubes.


The four are the most dangerous medical device malfunctions according to the FDA recall notice.

Avanos Medical Recalls Cortrak*2 Ental Access System for Feeding Tubes
Inadvertently removing nasogastric feeding tube tubes has resulted in 60 injuries as well as 23 deaths.

It is the most frequently reported cause of death for recalled devices.


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


Avanos Medical Cortrak 2 eternal access system If a nasogastric or Nasoenteric, tubes are improperly placed, patients may suffer damage to the vocal cords, their lungs or trachea. This could cause severe injury , and possibly death. As a precautionary measure, Avanos Medical sent warning to doctors to suggest that the hospital or user "...confirm the location of the NG/NI tubes in accordance with hospital protocols" Fox news reported.

Avanos Medical reported in a recall notification that the deaths and injuries caused by the improper placement or improper use of an enteral feeding tube while using the CORTRAK*2 Ental Access System.

Avanos Medical https://www.medscape.com/viewarticle/891200 Baxter recalls SIGMA Spectrum Infusion Systems with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems (Version 9)
Baxter has received 51 complaints of serious injuries. There were three cases of deaths in the past five years that could be associated with this issue.

The medical device maker Baxter has recalled the device following numerous reports of a malfunctioning alarm. The alarm on the pumps was unable to activate in the event of upstream occlusion events. Avanos Medical feeding tube These chemicals can trigger adverse health effects that could lead to death according to the announcement.

Medtronic Recalls NIMCACT Reforced EMG Endotracheal Tub
There have been 3 injuries and 2 deaths associated to the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube that are used to help provide airway as well as monitor laryngeal nerves during head and neck surgery - are the source of three accidents and two deaths before Medtronic's recall. Although Medtronic doesn't ask customers to replace damaged devices, the company sent out safety alerts in order to prevent the silicone cuff from blocking a patient’s airway.


If the tube fails to adequately ventilate or block the airway, patients could suffer from deprivation of oxygen, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System
The use of this device led to 2 injuries, and 1 deaths.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System because the in-line ventilator adapter could prevent patients who use home care in getting enough oxygen from their ventilators. Patients at risk include breathing in mucus respiratory failure (pneumonia) as well as brain injuries (hypoxia) and coughing.


This is a list containing human life lost due to the misuse of medical devices or their malfunction in 2022.


Avanos Medical Recalls Cortrak*2 Enteral Access System

Injuries: 60

Deaths: 23

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

Injuries: 51

Deaths: 3

Medtronic Recalls NIMCONTACT Reinforced Endotracheal Tube that has EMG Reinforcement and the NIM Standard Reinforced 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 Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls HVAD Pump 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. Recall of the HawkOne Directional Atherectomy Systems

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 Stent

Injuries: 9

Deaths: 0

Vyaire Medical Recalls bellavista1000e 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

Avanos Medical
My Website: https://www.medscape.com/viewarticle/891200