Reported Dec 19, 2018 · Terminated
UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050…
Neotract Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Neotract Inc · 4473 Willow Rd Ste 100 · Pleasanton, CA · 94588-8570
Is this the product you have?
- UroLift System REF Catalog NumberUL400-4
- Tray ContentsUroLift System with Handle Release
- Tool STERILE R CE 0050 Manufactured Byneotract
- Lot codes and dates
- Model
AN00141 (US) and AN00142 (OUS)Catalog No.: UL400-4
- Lots
P37940P37943P37953P37956P37965P37971P37985P37988P37995P38001P38013P38020P38124P38132
- Model
- Amount recalled
- 8,804
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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