NeoTract—UL400 UroLift Systems: Upon Implant Deployment, Capsular Tab May Not Be Delivered as Needle is Retracted
July 18, 2018 | Risk Management News
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In a July 6, 2018, Urgent Medical Device Recall 1st Notification letter submitted by ECRI Institute member hospitals, NeoTract (a Teleflex company) states that, upon implant deployment with the above systems, the capsular tab may not be delivered as the needle is retracted, resulting in the needle being deployed into the prostate and retracted, leaving no implant behind. NeoTract also states that failure to deliver a capsular tab may result in a delay in completing a treatment or an inability to complete a treatment for the patient. NeoTract further states that use of a recalled device may lead to increased frequency of existing known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle. NeoTract states that this problem affects only the delivery device; the UroLift implant is...