Notes

FDA's most dangerous recalls of 2022 - Food Feeding Tubes Leading (Avanos Medical)
As per FDA recalls, the Avanos Medical Cortrak2 is the most hazardous medical device.

2022 isn't even close to an end, yet the FDA's list for recalls of medical devices has already reached 50. The recalls have caused 36 deaths and 228 injuries. feeding tube placement Avanos Medical ranks number one on the 2022 list of malfunctions in medical devices with 23 deaths attributed to an improperly placed feeding tube.


These are the most dangerous medical device errors according to the FDA recall notice:

Avanos Medical Recalls Cortrak*2 Enteral Access System to feed tubes
Inadvertently taking out nasogastric tube feeding tubes caused 60 injuries and 23 deaths.

In 2022 the year 2022, the malfunction of this device was the main cause of death for all recalled medical equipment.


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


Patients may suffer serious injuries or even death if the nasogastric tub or nasoenteric one is wrongly placed. Avanos Medical notified that users "...and hospitals must confirm the location of the N/NI tubes in accordance with institution protocol. Avanos Mediacal Cortrak 2 Fox News reported.

Avanos Medical reported in a recall notification that injuries and deaths were caused by misplacement or use of tubes for feeding into the enteral system when employing the CORTRAK*2 Ental Access Systems.

Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9)
Baxter has received 51 reports about serious injuries and three cases of patient deaths possibly related to this issue in the last five years.

Baxter, a maker of medical devices has announced a recall of the device after numerous reports of a safety alarm failure. Avanos Mediacal Cortrak 2 The alarm on the pumps was failing to be activated in the case of upstream occlusion events. These products can cause adverse health effects that could result in death according to the announcement.

Medtronic Recalls NIMCACT Reforced Endotracheal Tube EMG
The use of the device led to 3 injuries, and 2 deaths.

Two deaths and three injuries were caused by the NIMCONTACT Reinforced EMG Endeotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube , which are used to track the laryngeal and head nerves. While Medtronic hasn't asked clients to return the damaged products, the company sent out safety notices to try to prevent the cuff made of silicone from blocking a patient’s airway.


https://www.openlearning.com/u/danielsenpuggaard-ro1i6x/blog/Cortrak2EasFromAvanosMedicalIncreasesPatientSafety If the tube is unable to ventilate properly or obstructs the airway, patients could suffer oxygen deprivation or brain damage. This could lead to 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 due to the fact that the inline ventilator adapter may hinder patients using home oxygen from receiving enough oxygen from their ventilators. Patients who are affected are choking on mucus, or other airway secretions lung infections (pneumonia) that prevents oxygen from reaching the bloodstream (respiratory failure) as well as brain injury due to a lack of oxygen to the brain (hypoxia) and even death.


This is the list of deaths of humans in 2022 due to medical device malfunctions or abuse.


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) Occlusion events

Injuries: 51

Deaths: 3

Medtronic recalls NIM CONTACT Reinforced-EMG 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 the HVAD Systems HeartWare Batteries

Injuries: 6

Deaths: 1

Philips Respironics Recalls All V60 Ventilators

Injuries: 4

Deaths: 1

Medtronic Recalls the HVAD Pump Implant Kit

Injuries: 2

Deaths: 1

Medtronic recalls the HeartWare HVAD Systems 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.) feeding tube placement Avanos Medical feeding tube 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 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


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