Cordis Precise PRO Rx US Carotid System Recalled Due to Dangerous Device Separation Risk
WASHINGTON, DC: – The US Food and Drug Administration has issued a Class I recall on the Cordis Precise PRO Rx US Carotid System due to a dangerous device separation defect. A Class I recall is the most serious recall and is applied to recalled products that may cause serious injury or death. Last February, Cordis recalled some lots of its “Precise Pro RX Carotid Stent Systems” after it was discovered to have a defect that caused “separation of the atraumatic distal tip of the sheathed delivery system in patients.”
The Precise Pro Rx is a medical device used to treat patients suffering from narrowed carotid arteries. The system includes a metal (nitinol) self-expanding stent that comes preloaded on a delivery catheter that is used to place the arterial stent.
According to the FDA’s recall release, the device might separate during the surgical procedure causing serious adverse events, such as embolization distally, stroke, and surgery to remove the separated tip from the carotid artery.
So far, there have been seven adverse events concerning this issue and the Precise Pro Rx carotid stent system. Five patients suffered injuries.
The affected products were manufactured from October 2019 until August 2020, and the affected units were distributed between December 6, 2019, and February 8, 2021. Cordis has recalled approximately 7,300 affected devices in the United States since issuing the recall on February 11, 2021.
Healthcare professionals and hospitals are asked to read the urgent medical device recall notice and to promptly check their inventory to ensure that they do not have any units in their possession. If any affected units are found, remove the units from the supply to make sure the affected devices are not used. Then complete, sign and return the Acknowledgement Form enclosed in the Urgent Medical Device Recall letter to Cordis.
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