August 20, 2014 — Cook Medical is recalling about 700 CloverSnare 4-Loop Vascular Retrieval Snares because the loop-snare can break off from the shaft, travel in a patient’s bloodstream, and cause a life-threatening embolism.
The CloverSnare consists of four “loops” made of metal wires that are packaged in a sheath. The device is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, such as wire guides, coils, balloons, catheters, and filters.
The problem is that the loop-snare can separate from the shaft. When this happens, the device will not function. The problem can also potentially cause embolization of snare fragments. When this happens, patients may need medical intervention or additional surgery to retrieve fragments.
There have been 6 reports of the loop snare detaching, including 4 cases that required medical intervention.
According to the recall notification:
“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.”
The recall affects 696 devices with Model Number VRS-6.0-9.0. These products were manufactured between August 2012 and August 2013 and sold between March 8, 2013 and July 1, 2014 in the United States, Canada, and many countries in Europe.
Customers were notified of the recall after Cook Medical initiated the recall on July 10, 2014. They were asked to return the recalled devices and report adverse events to the FDA.
Potential adverse events:
- Pulmonary embolism
- Heart attack
- Vessel perforation
- Device entrapment
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