UroLift UL400-4 (UDI 00814932020049)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00814932020049), received between Mar 5, 2020 and Sep 2, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K173087); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 24, 2022Class IIOpen, Classified

   There is the potential that during implant deployment, the device may not properly deliver a implant.

   Z-1502-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2020Fracture; Fracture

  ON 22 JULY 2020, NEOTRACT WAS INFORMED OF A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE DURING WHICH THE PHYSICIAN NOTED THAT THREE DEVICES APPEARED TO NOT DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM OR INJURY WAS REPORTED. ON 3 AUGUST 2020, NEOTRACT'S INVESTIGATION OF THE RETURNED DEVICES INDICATED THAT ONE DEVICE WAS MISSING 1MM OF THE NEEDLE TIP. NEOTRACT NOTIFIED THE PHYSICIAN OF THE INVESTIGATION RESULTS. ON (B)(6) 2020, THE PHYSICIAN ACKNOWLEDGED THE MISSING NEEDLE PIECE AND STATED THAT HE DID NOT FEEL FURTHER EVALUATION WAS WARRANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10484981 ↗
• MalfunctionMar 20, 2020Fracture; Fracture

  ON (B)(6) 2020, NEOTRACT WAS INFORMED OF A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE DURING WHICH THE PHYSICIAN COULD NOT VISUALIZE THE SUTURE AFTER NEEDLE DEPLOYMENT. NO PATIENT INJURY OR HARM WAS REPORTED. ON 20 FEB 2020, NEOTRACT'S INVESTIGATION OF THE DEVICE INDICATED THAT 2MM OF THE NEEDLE TIP WAS MISSING. NEOTRACT NOTIFIED THE PHYSICIAN OF THE INVESTIGATION RESULTS. ON 11 MARCH 2020, THE PHYSICIAN ACKNOWLEDGED THE MISSING NEEDLE PIECE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME DESPITE MULTIPLE OUTREACH ATTEMPTS. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9859631 ↗
• MalfunctionMar 5, 2020Fracture; Fracture

  ON 10 JAN 2020, NEOTRACT WAS INFORMED OF SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE DURING WHICH A DELIVERY DEVICE DID NOT DEPLOYED PROPERLY, THERE WAS NO PATIENT INJURY OR HARM REPORTED, AND THE DEVICE WAS RETURNED FOR INVESTIGATION. ON 04 FEB 2020, NEOTRACT'S DEVICE ANALYSIS CONFIRMED THAT A 1 -2MM NEEDLE TIP WAS MISSING FROM THE RETURNED DEVICE. NEOTRACT HAD NOTIFIED THE PHYSICIAN OF THE MISSING NEEDLE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793193 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173087. One submission often covers many models, so check the product and lot details in each record.

• Z-0598-2019 · Jul 6, 2018 · Terminated
  UroLift System REF Catalog Number: UL400-4 Tray Contents: UroLift System with Handle Release Tool STERILE R CE 0050 Manufactured By: neotract