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Deadliest FDA Recalls 2022 - Misplaced Feeding Tubes Leading

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Based on FDA recalls, the Avanos Medical Cortrak2 feeding tube is the top deadliest medical device.

The year 2022 hasn’t come to an end, yet the FDA’s list of recalled medical devices is already at 50. The impact of these recalls thus far is an unfortunate 36 deaths and 224 injuries. Avanos Medical ranks first on the 2022 list of medical device malfunctions with 23 reports of death caused by misplaced feeding tubes.

These are the 4 deadliest medical device malfunctions according to the FDA medical device recall notice:

Avanos Medical Recalls Cortrak*2 Enteral Access System for feeding tubes

The misplacement of nasogastric feeding tubes resulted in 60 injuries and 23 deaths.

COPYRIGHT_WI: Published on https://washingtonindependent.com/ebv/deadliest-fda-recalls-2022-misplaced-feeding-tubes-leading/ by Marty MC on 2022-10-16T13:13:01.505Z

This device malfunction is the biggest cause of death of all recalled medical devices by the FDA in 2022.

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 placed incorrectly.

In cases where a nasogastric or nasoenteric tube is inserted incorrectly, patients could experience damage to the vocal cords, lungs, or trachea, all of which can lead to serious injury or death. As a precaution, Avanos Medical sent notice to providers, suggesting that the hospital or user "…confirm the placement of the NG/NI tubes per institution protocol" Fox news reported.

Avanos Medical's recall communication reported the injuries and deaths related to the misplacement of the enteral feeding tubes while using the CORTRAK* 2 Enteral Access System since 2015.

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 of serious injuries and three reports of patient deaths over five years potentially associated with this issue.

The medical device manufacturer Baxter recalled this device after numerous reports of a safety alarm malfunction. The alarm on the pumps was failing to trigger in the event of upstream occlusion events. The announcement warned that using these affected products may cause adverse health effects, including death.

Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube

There have been 3 injuries and 2 deaths associated with the use of this device.

The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube - which are used to provide an airway and monitor laryngeal nerves during head and neck surgery - have been the cause of three injuries and two deaths ahead of Medtronic’s recall. The company isn’t asking customers to return or replace the affected devices but sent out safety notices to prevent the device’s silicone cuff from obstructing a patient’s airway.

If the tube does not ventilate properly or obstructs the airway, patients may suffer oxygen deprivation, brain damage, or death.

Baxter Healthcare Corporation Recalls Volara System

There has been 1 injury and 2 deaths associated with the use of this device.

Baxter Healthcare Corporation and its subsidiary company Hillrom are recalling the Volara System because the in-line ventilator adaptor may prevent home-use patients from getting enough oxygen from their ventilators. The risks to affected patients include choking on mucus or other airway secretions, lung infection (pneumonia) that prevents oxygen from getting to the blood (respiratory failure), brain injury caused by lack of oxygen to the brain (hypoxia), and death.

This is a list of human life paid in 2022 for medical device malfunction or misuse:

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) occlusion events

Injuries: 51

Deaths: 3

Medtronic Recalls NIM CONTACT Reinforced EMG 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 Recalls Certain Medfusion 3500 and 4000 Syringe Infusion 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 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.) 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 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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