CloverSnare 4-Loop Recall Issued Over Pulmonary Embolism Risk
Following at least four reports of injuries, federal regulators are warning that a device used to retrieve items from the cardiovascular system may lead to the very injuries it was designed to prevent.
The FDA gave a Cook CloverSnare 4-Loop Vascular Retrieval Snare recall its most serious designation this week, indicating that continued use of the device may pose a risk of serious injury or death, as the tip of the snare may be prone to break off during use.
The action was given a Class I recall designation shortly after the company announced the recall in a press release on August 26.
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The Cook CloverSnare 4-Loop Vascular Retrieval Snare is used to manipulate and retrieve items in the cardiovascular system, usually blood vessels. It is often used to maneuver temporary implanted devices, such as vena cava filters, broken devices, guide wires, coils, balloons and catheters.
The recall warns users that the snare loop may separate from the shaft, possibly causing embolization, or blocking of the blood vessels, with the device fragments. If this happens, the snare loop may travel through the vascular system and become stuck in other organs, like the heart and the lungs.
The FDA warns additional interventions may be necessary to retrieve the snare loop if separated from the patient. This will also cause the device to stop working.
The problems caused by the recalled device may cause serious side effects, health concerns and may result in death.
The recall affects Cook CloverSnare 4-Loop Vascular Retrieval Snarea with model number VRS-6.0-9.0 and manufacturing dates of August 2012 through August 2013. The devices were distributed from March 8, 2013, through July 1, 2014. Nearly 700 were distributed nationwide.
The snares are manufactured by Cook Inc. In Bloomington, Indiana.
Cook Medical distributed an Urgent Medical Device Recall letter to customers on July 17 informing them of the problem and actions which need to be taken. Cook also instructed customers to separate the affected unused products from inventory, collect the defective used devices and return all unused products to the company.
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