Implantable Transprostatic Tissue Retractor System
Gastroenterology, Urology · 21 CFR 876.5530
The treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.
Recent MDR events
471 adverse event reports on file
- IMPLANTABLE TRANSPROSTATIC TISJul 29, 2026MalfunctionNeotract, Inc.3015181082-2026-00055
- IMPLANTABLE TRANSPROSTATIC TISJul 29, 2026MalfunctionNeotract, Inc.3015181082-2026-00054
- IMPLANTABLE TRANSPROSTATIC TISJul 29, 2026MalfunctionNeotract, Inc.3015181082-2026-00056
- IMPLANTABLE TRANSPROSTATIC TISJul 29, 2026MalfunctionNeotract, Inc.3015181082-2026-00057
- IMPLANTABLE TRANSPROSTATIC TISJul 29, 2026MalfunctionNeotract, Inc.3015181082-2026-00058
- URO CLIPJul 14, 2026MalfunctionTeleflex Incorporated25811732
- UROLIFT UL400 DELIVERY DEVICE & IMPLANTJul 14, 2026MalfunctionNeotract, Inc.3015181082-2026-00053
- UROLIFT 2 IMPLANT CARTRIDGE HANDLE KITJul 10, 2026MalfunctionNeotract, Inc.3015181082-2026-00052
- UROLYFTJul 8, 2026InjuryTeleflex Medical LlcMW5190465
- UROLIFT 2 IMPLANT CARTRIDGEJul 8, 2026InjuryNeotract, Inc.3015181082-2026-00050
Event type breakdown
Recalls
2 recall events for this product code
- Neotract IncOpen, ClassifiedAug 5, 2022
UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
There is the potential that during implant deployment, the device may not properly deliver a implant.
Z-1502-2022 · View FDA record ↗ - Neotract IncTerminatedUnknown
UroLift System
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.
Z-0598-2019 · View FDA record ↗
Registered firms
31 firms currently registered for this product code
Teleflex Llc (nadc)
Olive Branch, MS, US
Teleflex Medical De Tecate, S. De R.l De C.v.
TECATE Baja California, MX
Sterigenics Us Llc
West Memphis, AR, US
Sterigenics U.s. Llc
Hayward, CA, US
Sterigenics U.s., Llc
Corona, CA, US
Teleflex Medical Llc
Morrisville, NC, US
Neotract, Inc.
Pleasanton, CA, US
The Laryngeal Mask Company (m) Sdn. Bhd.
Kulim Kedah, MY
510(k) clearances
11 clearances for this product code
- Neotract, Inc.Sep 22, 2023
K232558 · UroLift 2 ATC Advanced Tissue Control System
- Neotract, Inc.Jul 31, 2020
K201837 · UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge
- Neotract, Inc.Jun 5, 2020
K200441 · UroLift Advanced Tissue Control (ATC) System
- Neotract, Inc.Dec 20, 2019
K193269 · UroLift System (UL400)
- Neotract, Inc.Mar 21, 2019
K190377 · UroLift System UL400
- Neotract, Inc.Dec 28, 2017
K173087 · UroLift System (UL400 and UL500)
- Neotract, Inc.Aug 18, 2017
K172359 · UroLift System (UL500)
- Neotract, Inc.Sep 21, 2016
K162345 · UroLift System UL500, UroLift Delivery Handle, UroLift Implant Cartiridge