Neotract Recalls
2 recalls on record · December 19, 2018 to August 10, 2022 · Medical Devices
Recalls by year
18
22
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 10, 2022Medical DevicesFDA
Neotract Inc recalls UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
Hazard: There is the potential that during implant deployment, the device may not properly deliver a implant.
December 19, 2018Medical DevicesFDA
Neotract Inc recalls UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050
Hazard: Upon implant deployment, the Capsular Tab may not be delivered as the needle is retracted. In this failure mode, the needle is deployed into the prostate and retracted, leaving no implant behind. 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. Use of a recalled device may lead to increased frequency of exiting known risks associated with the product, including bleeding and tissue trauma associated with delivering the needle.