Question

Find a recently recalled medical device that has been pulled from the market and report on why the device was recalled, what adverse events were caused, the root cause for the adverse event and how the company responded when they found about the defect. Report on whether you think the company and the FDA handled this event appropriately.

Answer 1

Pipeline flex embolization is a recent pulled off device in market.

It is a permanent mesh cylinder (stent)used in brain aneurysm that bulge or ballon out the sides of blood vessel.

It is recalled because the delivery system could fracture while placing the stent. Fractured peices may remain inside the brain blood flow and trying to retrieve them could worsen the condition.

This can also cause other serious consequences such as blood vessel blockade,stroke and death.

Fdi recieved 50 medical reports with 10 deaths.And issued order to pull it off.

In response company Medtronic sent urgent notice to users and patient to not use the product further and return the unused one to medtronics.

So fdi and company, medtronics handle situation with utmost care.