3d revascularization device 의 안전성 경고

Safety alert

2017-07-24

2017-07-24

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20170724.html

Medical device safety alert: penumbra 3d revascularization device the united states food and drug administration (fda) has issued a medical device safety alert concerning penumbra 3d revascularization device, manufactured by penumbra inc. [lot numbers: c00644, c00645, c00646, c00717; distribution dates: 15 may 2017 to 7 june 2017; manufacturing dates: 21 march 2017 to 28 april 2017] the manufacturer is recalling the penumbra 3d revascularization device because there is a risk of the delivery wire breaking or separating during use. fractured pieces of the delivery wire could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the stroke worse. this can also cause other serious adverse health consequences such as continued blockage of blood vessels, completion of the stroke, and death. affected users are advised to identify and remove any affected 3d revascularization devices from inventory and quarantine. for details, please refer to the fda websites: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm567913.Htm https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm567990.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 july 2017.