Alerta De Seguridad para Hydrofinity Hydrophilic Guidewire

Safety alert

2014-06-19

2014-06-19

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20140619a.html

Medical device safety alert: nitinol devices & components hydrofinity hydrophilic guidewire the united states food and drug administration (fda) has issued a medical device safety alert concerning hydrofinity hydrophilic guidewires, manufactured by nitinol devices & components, inc. the manufacturer announced a voluntary recall of the hydrofinity hydrophilic guidewires due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. vessel occlusion may necessitate surgical intervention to resolve. two cases were reported where the polymer jacket separated from the device and embolized. one case required surgical intervention. for details, please refer to the fda websites:http://www.Fda.Gov/safety/recalls/ucm401753.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2014.