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

Catalog Number	UL2-C
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.

• Brand Name: UroLift 2 Implant Cartridge
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 50212471
• Report Number: 3015181082-2026-00062
• Device Sequence Number: 20361149
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UL2-C
• Device Lot Number: 73E2500372
• 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: 07/17/2026
• Supplement Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: n/a; n/a.
• Patient Sex: Male