EMBOL-X Glide Protection System 의 안전성 경고

Safety alert

2013-10-02

2013-10-02

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20131002c.html

Medical device safety alert: edwards lifesciences embol-x glide protection system the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning embol-x glide protection system manufactured by edwards lifesciences ltd. the affected model numbers are exgf24, exgf24ll, exgf24mm, exgf24ss, exgf24xl, exgf24xs. through a complaint investigation, edwards lifesciences has identified a potential health risk to patients undergoing cardio pulmonary by-pass surgery when using the embol-x glide protection system. the reported complaint involved a deformed tip of the cannula that is part of the embol-x glide protection system, this was confirmed during product evaluation. as a result, the manufacturer is recalling all lot numbers of the embol-x glide protection system cannulae that have not expired. no patient injury was reported with the use of this device. the manufacturer believes that risk of injury to patients from this issue is possible; if the defect is not noticed during preparation, when force applied to the tip during insertion or removal, it may lead to a separation and embolize. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con316301 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 2 october 2013.