AFX Inducer Recall Issued by Enologix After Breaking During Procedures

August 24, 2013


afxEndologix recalled its AFX Introducer System due to some potentially serious ramifications associated with its use.

Recently, the FDA has assigned its most serious warning to the catheter-insertion device since the organization feels the product could cause serious injury or death during use.

What is the AFX Introducer System?

The AFX Introducer System’s purpose is to introduce medical devices and catheters into a patient’s blood vessels during medical procedures to ensure minimal blood loss. It was manufactured from April 1, 2013 through April 30, 2013. It was distributed in New York, New Jersey, New Hampshire, Michigan, Indiana and in Florida.

Whose idea was it to recall the device?

Endologix sent its customers a recall notice on May 13, 2013. The letter stated the following:

“Do not use or further distribute any affected product.”

On May 21st, Endologix expanded its recall by mailing a notification letter to additional customers encouraging patients and healthcare professionals alike to report any adverse events or side effects associated with the use of the product.

What prompted the recall?

The company launched the recall as a response to reports claiming the device’s dilator could break during implantation procedures. If a breakage occurs during the implantation process, it can result in a patient’s injury or death.

Why do recalled products matter?

Recalls such as stated above are very important to the public’s safety. When medical professionals depend on a product to perform a certain job and the product fails in any fashion, it can lead to a patient’s death or serious injury. The AFX Inducer recall is an example of just such a product.

Have You Been Injured by a Faulty or Dangerous Product? Our Injury Law Team May Be Able to Help!

If you or someone you love has been injured due to a faulty product, call Abrahamson & Uiterwyk for a free consultation. You could be entitled to compensation for injuries sustained due to a product malfunction.

To find out if you could qualify for compensation, call our injury law team today at 727-472-4021.

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