UROLIFT IPN923351Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10814932020282), received between Feb 6, 2023 and Apr 10, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2023Break; Break

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. THE CASE WAS ABORTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING WHICH WAS CONTROLLED USING A MONOPOLAR ELECTRODE, AND A CATHETER WAS PLACED. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023 NOTED THAT A FRAGMENT OF A BROKEN SCOPE SEAL WAS RETURNED. THE OTHER PORTION OF THE BROKEN SCOPE SEAL WAS NOT RETURNED; THEREFORE, IT IS UNABLE TO BE DETERMINED IF THERE IS A MISSING FRAGMENT(S). THE PHYSICIAN WAS NOTIFIED AND REPORTED THAT THE PATIENT IS DOING FINE AND HE WILL CONTINUE TO SEE THE PATIENT REGULARLY TO ENSURE THAT THE PATIENT CONTINUES TO DO WELL.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16707608 ↗
• MalfunctionMar 14, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE, IT WAS NOTED THAT THE SCOPE LOCK LEVER DISLODGED FROM THE UROLIFT 2 HANDLE. INVESTIGATION OF THE RETURNED DEVICE ON 13 FEBRUARY 2023 CONFIRMED THAT THE COVER PLATE SUBASSEMBLY WAS BROKEN IN THE REGION WHERE THE CYSTOSCOPE IS INSERTED AND THAT A 5MM FRAGMENT AND A 1.2MM FRAGMENT WERE UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND INDICATED THAT NO FURTHER FOLLOW UP ACTION WAS PLANNED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16541835 ↗
• MalfunctionMar 2, 2023Fracture; Fracture

  ON 25 JANUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE, IT WAS REPORTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. A PORTION OF THE NEEDLE TIP DETACHED FROM THE DEVICE ADHERED TO THE PATIENT¿S PROSTATIC TISSUE, WHICH WAS REMOVED BY THE PHYSICIAN USING GRASPERS. INVESTIGATION OF THE RETURNED DEVICE AND NEEDLE FRAGMENT ON (B)(6) 2023 IDENTIFIED THAT APPROXIMATELY 2MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED, AND STATED THEY WOULD OBSERVE THE PATIENT¿S CONDITION. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16473527 ↗
• MalfunctionFeb 6, 2023Break; Break

  ON 15 DECEMBER 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, ONE DEVICE DID NOT SUCCESSFULLY DEPLOY AN IMPLANT. DURING THE INVESTIGATION OF THE RETURNED DEVICE ON 9 JANUARY 2023 , IT WAS NOTED THAT LESS THAN 1 MM OF THE CUTTER WAS BROKEN AND MISSING FROM THE RETURNED DEVICE. THE PHYSICIAN WAS NOTIFIED, AND STATED HE WAS CONFIDENT NO PORTION OF THE DEVICE REMAINED IN THE PATIENT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16309256 ↗