EMMC Device Investigation Triggers FDA Recall

John Krinjak

Updated 10 months ago


A discovery during surgery at Eastern Maine Medical Center in Bangor has led to a nationwide recall of a device that helps prevent blood clots.

It’s called the Cordis Opt-ease Vena Cava Filter…and it’s inserted into a vein that returns blood to the heart from the legs.

The filter catches blood clots to prevent a recurrent pulmonary embolism, which is a life-threatening condition.

“So this was discovered as we were taking the device out after a patient didn’t need it anymore, and it was discovered when they were removing it, an interventional radiologist, as they were removing it, it was very difficult. I said I want someone to take a look at this device and make sure it isn’t defective,” said Dr. James Raczek, Senior Vice President at EMMC.

Turns out the device itself wasn’t defective, but the instructions on how to insert it were not correct.

That led to an FDA recall of the device and changing the labeling.

EMMC received an award from the FDA for catching the issue.


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