August 20, 2014 — The U.S. Food and Drug Administration (FDA) has announced a recall for the CloverSnare 4-Loop Vascular Retrieval Snare because it can break and cause an embolism.
At least six incidents have been reported, including four requiring medical intervention.
The CloverSnare is designed with four metal wires arranged in “loops” that are deployed from a sheath. The device is used to retrieve foreign objects from a patient’s cardiovascular system, such as catheters, filters, balloons, coils, and wire guides.
If the loop-snare detaches from the shaft, the device will not function. Fragments of the snare can also travel in a patient’s bloodstream and clog blood vessels (called an “embolization”). Treatment for this life-threatening complication may involve additional surgery or medical intervention.
According to Cook Medical:
“In six cases, customers reported separation of the loop snare from the shaft during use. The separation was caused by the application of lateral force to the snare in an effort to change the shape of the device. In four cases of separation, medical intervention to retrieve the separated snare was required.”
Cook Medical began the recall on July 10, 2014. Customers were instructed to return the device and report adverse events. The recall affects 696 devices with Model Number VRS-6.0-9.0. They were sold from March 8, 2013 through July 1, 2014 in the United States, Canada, and Europe.
Vascular retrieval injuries may include:
- Embolization
- Stroke
- Pulmonary embolism
- Heart attack
- Vessel perforation
- Device entrapment
Do I have a Vascular Retrieval Injury Lawsuit?
The Schmidt Firm, PLLC is currently accepting CloverSnare Vascular Retrieval System induced injury cases in all 50 states. If you or somebody you know has been injured by an embolism or other side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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