Neotract recalls UroLift System REF UL400-4 (QTY 4) with Handle Release Tool due to potential failure to properly deliver implants during deployment. Affected units have specific lot numbers and UDI/DI codes.
There is the potential that during implant deployment, the device may not properly deliver a implant.
Neotract is recalling 4 units of the UroLift System REF UL400-4 with Handle Release Tool because there's a risk the device might not properly deliver implants during surgery. This could lead to improper treatment outcomes for patients needing urological procedures.
The device may fail to deliver implants correctly during surgical implantation. This could result in the implant not functioning as intended, potentially requiring additional procedures or affecting treatment effectiveness.
Patients who have received the UroLift System REF UL400-4 with Handle Release Tool for urological procedures are affected. Medical professionals using this specific model during implant deployment are at risk of improper treatment outcomes.
Check for the UroLift System REF UL400-4 with Handle Release Tool. Affected units have specific lot numbers and UDI/DI codes listed in the recall notice: 00814932020049, 00814932020001, and the listed lot numbers (e.g., 73M2100393, 73A2200670).
Identify if your UroLift System REF UL400-4 with Handle Release Tool has the listed lot numbers or UDI/DI codes.
The recall is due to potential failure to properly deliver implants during deployment, which could lead to improper treatment outcomes.
The UroLift System REF UL400-4 with Handle Release Tool, identified by specific lot numbers and UDI/DI codes listed in the recall notice.
Check the lot numbers and UDI/DI codes on your product against the list provided in the recall notice.
We’ve drafted a message you can send Neotract to request your refund or repair — edit it as you like.
Subject: Recall Z-1502-2022 — Neotract Neotract Hello, I own a Neotract that is covered by recall Z-1502-2022 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.