Medical Device recall due to possible device breakage when in use. Vyaire Medical....

Health care providers typically place endotracheal tubes into a patient’s airway (trachea) to help establish and maintain their airway and to ensure the adequate exchange of oxygen and carbon dioxide. The Vyaire Medical Tri-Flo Subglottic Suction System can be used to remove liquids or semisolids that block an adult patient’s airway when an endotracheal tube is in place.

Reason for recalling the product:
Vyaire Medical Inc is recalling the Tri-Flo Subglottic Suction System because there is a risk that the distal soft tip of the catheter may break off and enter the patient’s lungs.

This may result in serious adverse health consequences including choking, wheezing, additional surgery to remove the tip from the patient’s lungs, irritation and reddening of the skin (erythema) of the airways, infections or death.

FDA consideration:
The FDA has identified this recall as a Class 1 recall, which is the most serious form of recall. This is due to the potential serious effects if a device breakage were to occur while in use.

FDA statement >>>
Medical Device Risk Evaluation

Medical Device Risk Evaluation

Unfortunately, Medical Devices can and do fail while in use. How best to prevent? Clearly, all medical devices need to undergo comprehensive design validation which is based on risk assessments which identify the high-risk areas, if indeed a product or component of a product were to fail. Once fully validated, there remains a need to ensure ongoing effective process controls and monitoring of materials and suppliers needs to be in place to ensure no degradation of the product due to lower quality materials getting into the supply chain.


Further information:
Medical Device Risk Management >>>
Supplier evaluation and rating >>>
Standard Operating Procedure >>>
Quality Risk Management – FDA >>>
European Medical Device Regulatory approval process >>>
Why Validate a Medical Device >>>

Medical Device Validation, information and training presentation >>>