UROLIFT IPN924185Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10814932020350), received between Aug 2, 2023 and Mar 31, 2025 — classified as 6 malfunctions.

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

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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2025Misfire; Misfire

  ON JANUARY 28, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿A 72 YEAR OLD MALE PATIENT WITH A 36 GRAM PROSTATE AND NO KNOWN PRE-EXISTING UROLOGICAL CONDITIONS, UNDERWENT AN IN-OFFICE PROCEDURE THAT WAS PERFORMED UNDER A PROSTATE BLOCK AND NITROUS GAS. DURING THE FIRST IMPLANT ATTEMPT, THE PHYSICIAN FOLLOWED THE STANDARD TECHNIQUE, STARTING AT THE BLADDER NECK, ANGLING THE HANDLE AT 10 O¿CLOCK WITH 5¿10 DEGREES OF COMPRESSION, AND PULLING THE TRIGGER THREE TIMES, BUT NO SUTURE WAS VISIBLE IN THE KEYHOLE. FOLLOWING GUIDANCE, HE WITHDREW THE DEVICE AND PERFORMED THE FOURTH PULL ON THE SIDE TABLE, BUT NO IMPLANT WAS RELEASED. THE BACK OF THE CARTRIDGE WAS CHECKED, AND NO BUCKLE WAS FOUND. A SECOND ATTEMPT WITH A NEW CARTRIDGE FOLLOWED THE SAME STEPS, YIELDING THE SAME RESULT. A THIRD ATTEMPT WITH A NEW HANDLE, WITH CAREFUL HAND MOVEMENTS, ALSO FAILED. OBSERVING BOTH THE PHYSICIAN¿S HANDS AND THE SCREEN, THE REPRESENTATIVE CONFIRMED PROPER TECHNIQUE WAS FOLLOWED. AFTER ABORTING THE PROCEDURE, AN INVESTIGATION ON THE SIDE TABLE SHOWED THAT ALL THREE CARTRIDGE INDICATORS WERE RECESSED AS IF AN IMPLANT HAD BEEN PLACED. WHEN RUNNING THROUGH THE FOUR TRIGGER PULLS ON SPENT CARTRIDGES, THE CAPSUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732112 ↗
• MalfunctionMar 31, 2025Misfire; Misfire

  ON JANUARY 28, 2025, NEOTRACT HAS BEEN MADE AWARE THAT ¿A 72 YEAR OLD MALE PATIENT WITH A 36 GRAM PROSTATE AND NO KNOWN PRE-EXISTING UROLOGICAL CONDITIONS, UNDERWENT AN IN-OFFICE PROCEDURE THAT WAS PERFORMED UNDER A PROSTATE BLOCK AND NITROUS GAS. DURING THE FIRST IMPLANT ATTEMPT, THE PHYSICIAN FOLLOWED THE STANDARD TECHNIQUE, STARTING AT THE BLADDER NECK, ANGLING THE HANDLE AT 10 O¿CLOCK WITH 5¿10 DEGREES OF COMPRESSION, AND PULLING THE TRIGGER THREE TIMES, BUT NO SUTURE WAS VISIBLE IN THE KEYHOLE. FOLLOWING GUIDANCE, HE WITHDREW THE DEVICE AND PERFORMED THE FOURTH PULL ON THE SIDE TABLE, BUT NO IMPLANT WAS RELEASED. THE BACK OF THE CARTRIDGE WAS CHECKED, AND NO BUCKLE WAS FOUND. A SECOND ATTEMPT WITH A NEW CARTRIDGE FOLLOWED THE SAME STEPS, YIELDING THE SAME RESULT. A THIRD ATTEMPT WITH A NEW HANDLE, WITH CAREFUL HAND MOVEMENTS, ALSO FAILED. OBSERVING BOTH THE PHYSICIAN¿S HANDS AND THE SCREEN, THE REPRESENTATIVE CONFIRMED PROPER TECHNIQUE WAS FOLLOWED. AFTER ABORTING THE PROCEDURE, AN INVESTIGATION ON THE SIDE TABLE SHOWED THAT ALL THREE CARTRIDGE INDICATORS WERE RECESSED AS IF AN IMPLANT HAD BEEN PLACED. WHEN RUNNING THROUGH THE FOUR TRIGGER PULLS ON SPENT CARTRIDGES, THE CAPSUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21732098 ↗
• MalfunctionJan 6, 2025Fracture; Fracture

  ON (B)(6) 2024, NEOTRACT HAS BEEN MADE AWARE BY A [PHYSICIAN] THAT ¿[PHYSICIAN] PERFORMED UROLIFT PROCEDURE ON (B)(6) 2024, THE FIRST IMPLANT WAS PLACED PROXIMALLY, BUT THE DEVICE DID NOT PERFORM AS EXPECTED DURING PULL 2. IT APPEARED THAT THE NEEDLE BROKE DURING DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT, AND UPON INSPECTION, THE NEEDLE WAS CONFIRMED TO BE BROKEN. THE BROKEN NEEDLE WAS REMOVED FROM THE PATIENT, AND A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE.¿ ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024, CONFIRMED THAT NO PART OF THE NEEDLE WAS LEFT IN THE PATIENT AND THE NEEDLE, THE CARTRIDGE, AND ENDOSCOPIC IMAGES WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084785 ↗
• MalfunctionNov 27, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT, WHICH REQUIRED REMOVAL OF THE IMPLANT THROUGH THE SHEATH. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED, AND NO PATIENT ADVERSE EVENTS WERE REPORTED. INVESTIGATION OF THE RETURNED DEVICE ON 31 OCT 2023 CONFIRMED THAT APPROXIMATELY 1.5MM OF THE NEEDLE TIP WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND STATED THAT NO FURTHER FOLLOW-UP ACTION WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212966 ↗
• MalfunctionNov 21, 2023

  DURING THE UROLIFT PROCEDURE, SURGEON WENT TO PLACE IMPLANT AND THE HANDLE WAS SQUEEZED BUT NOT DEPLOYED. ACCORDING TO THE SURGEON, THE HANDLE WAS NOT CUTTING THE TAB AND THE SURGEON FELT THE HANDLE WAS MALFUNCTIONING. ANOTHER UROLIFT HANDLE WAS OPENED AND THE REMAINING IMPLANTS WERE PLACED WITHOUT ANY PROBLEMS. THE PROCEDURE WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181599 ↗
• MalfunctionAug 2, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT; THEREFORE, THE DEVICE WAS REMOVED FROM THE PATIENT THROUGH THE SHEATH. IT WAS NOTED THAT ONCE THE DEVICE WAS REMOVED FROM THE SHEATH, THE NEEDLE HAD BROKEN OFF. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL IMPLANTS, AND IT WAS NOTED THAT THE PATIENT ONLY HAD MILD BLEEDING. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023 CONFIRMED THAT 38MM OF THE NEEDLE WAS BROKEN BUT WAS INCLUDED WITH THE RETURNED DEVICE, AND THE ENTIRE LENGTH OF THE NEEDLE WAS ACCOUNTED FOR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17444847 ↗