Filter Designed to Catch Patient Blood Clots Focus of Nationwide Recall

 Posted on February 28, 2014 in Defective Medical Devices

Doctors doing surgery at a hospital in Maine made a discovery regarding the Cordis Opt-ease Vena Cava Filter that have led to investigation and defective device recalls for the item.

The filter is supposed to catch clotted blood traveling through the Vena Cava to hold it there so that the clot doesn't travel farther into the heart or lungs. Doctors struggled to remove the filter from a patient who no longer required it, finding that the instructions for insertion and removal were not accurate.

The filter can also be dislodged in the body, which can be identified using x-rays. Surgery will be needed to reposition or replace the filer if this condition occurs. The filter is not designed for long—term use, since it's supposed to be removed after the patient no longer needs it. Difficulty removing the filter can lead to other complications for the patient involved. Recurrent pulmonary embolism is a life-threatening condition.

Upon discovery of this issue, the FDA issued a recall regarding the labeling instructions that affected 33,000 filters in the United States that were distributed between 2010 and 2013.

The product is still listed as being recalled on the FDA website, where doctors or others who received faulty instructions can complete a report on the issue. Improper labeling is a serious concern with medical devices since the healthcare staff in charge of using them may cause pain or future problems for the patient. The FDA monitors and issues these recalls as a way to stop the spread of the problem, but patients can still be impacted by faulty labeling.

If you have been a victim of faulty labeling or instructions with a medical device, you need a consultation with an Illinois defective medical device attorney.