MAUDE Adverse Event Report: NeoTract, Inc. UroLift 2 Implant Cartridge Handle Kit; IMPLANTABLE TRANSPROSTATIC TIS

Catalog Number	UL2-CHK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• Brand Name: UroLift 2 Implant Cartridge Handle Kit
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TIS
• Manufacturer (Section D): NeoTract, Inc.; pleasanton
• Manufacturer (Section G): NeoTract, Inc.; 4155 hopyard road; pleasanton 94588 ; CA 94588
• Manufacturer Contact: tatiana kosterina ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 50786576
• Report Number: 3015181082-2026-00079
• Device Sequence Number: 15813215
• Product Code: PEW
• UDI-Device Identifier: 10814932021470
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/03/2024
• Device Catalogue Number: UL2-CHK
• Device Lot Number: 73A2300109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male