Neotract recalls UroLift System REF UL400-4 due to risk of failed implant delivery, potentially causing treatment delays or incomplete procedures. Affected units include specific catalog numbers and lots.
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.
Neotract is recalling its UroLift System REF Catalog Number UL400-4 because the Capsular Tab may not be delivered during implant deployment. This could lead to treatment delays or incomplete procedures, increasing risks like bleeding and tissue trauma.
The Capsular Tab may not be delivered properly when the needle is retracted during implant deployment. This can cause the needle to be deployed into the prostate and retracted without leaving the implant, leading to treatment delays or incomplete procedures. The risk includes increased bleeding and tissue trauma during the procedure.
Patients who have received the UroLift System REF UL400-4 for prostate treatment are affected. Those with the specific catalog numbers and lots listed are most at risk.
Check for the UroLift System with Handle Release Tool in the tray. Affected units have catalog number UL400-4 and specific lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132.
Identify the catalog number and lot numbers on the UroLift System package to determine if it is affected.
The recalled model is UroLift System REF Catalog Number UL400-4 with specific lots: P37940, P37943, P37953, P37956, P37965, P37971, P37985, P37988, P37995, P38001, P38013, P38020, P38124, P38132.
The Capsular Tab may not be delivered properly during implant deployment, which could lead to treatment delays or incomplete procedures and increased risks of bleeding and tissue trauma.
Check the catalog number and lot numbers on the product to see if it is affected. If it is, contact Neotract for further instructions.
We’ve drafted a message you can send Neotract to request your refund or repair — edit it as you like.
Subject: Recall Z-0598-2019 — Neotract Neotract Hello, I own a Neotract that is covered by recall Z-0598-2019 from Neotract. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
