UROLIFT IPN929207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10814932020459), received between Dec 5, 2024 and Sep 9, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (1 report).

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.

• MalfunctionSep 9, 2026Firing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690138 ↗
• MalfunctionNov 19, 2025Material Rupture; Material Rupture

  IT WAS REPORTED " NOTICED THROUGHOUT THE PROCEDURE CARTRIDGES WERE SLIGHTLY MORE DIFFICULT TO INSERT BUT STILL SEEMED TO BE LOCKING IN PROPERLY. BEFORE PLACING THE 6TH IMPLANT, THE DELIVERY SYSTEM NEEDED TO BE RESET. IT SEEMED LIKE THE TRIGGER HADN'T BEEN FULLY RETRACTED AFTER LAST IMPLANT DELIVERY. PHYSICIAN SUCCESSFULLY INSERTED ATC CARTRIDGE INTO DELIVERY SYSTEM AND ATTEMPTED PLACEMENT ON PATIENTS LEFT PROXIMAL SLIGHTLY ANTERIOR TO FIRST PROXIMAL IMPLANT. AFTER RETRACTING NEEDLE/3RD PULL THE KEYHOLE SHOWED METAL THAT LOOKED LIKE THE NEEDLE, NOT A CT OR UE. SUCCESSFULLY REMOVED DELIVERY SYSTEM BUT THE TIP OF DELIVERY SYSTEM SHOWED THE NEEDLE WAS BROKEN IN HALF. WE USED VO TO LOOK INSIDE PATIENT AND SAW NEEDLE TIP FLOATING AT THE BASE OF THE BLADDER. PHYSICIAN USED A GRASPER TO REMOVE TIP OF NEEDLE THROUGH RIGID CYSTO SHEATH. PATIENT HAD SOME IRRITATION TO THE BLADDER WALL FROM NEEDLE WHICH RESULTED IN PLACEMENT OF A CATHETER. PATIENT HAD CATHETER REMOVED NEXT DAY AND DOES NOT REPORT ANY ADDITIONAL CONCERNS".

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23594425 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, NEOTRACT HAS BEEN MADE AWARE BY A [PHYSICIAN] THAT ¿TWO PATIENTS WHO UNDERWENT THE PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2024, REQUIRED READMISSION TO THE HOSPITAL DUE TO HEMATURIA AND CLOT RETENTION. ACCORDING TO [PHYSICIAN], ONE PATIENT REQUIRED A RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. [PHYSICIAN] NOTED THAT BLEEDING EVENTS OF THIS NATURE ARE NOT UNCOMMON FOLLOWING BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURES.¿ ON (B)(6) 2024, A LABEL PHOTO OF THE DEVICE WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 12, 2024, INDICATED THAT FOUR HOURS AFTER UNDERGOING THE UROLIFT PROCEDURE, THE PATIENT EXPERIENCED HEMATURIA AND CLOT RETENTION. THE PATIENT WAS ALREADY ADMITTED TO THE HOSPITAL AT THE TIME AND UNDERWENT SURGICAL INTERVENTION TO REMOVE THE CLOTS. THE PATIENT¿S CONDITION WAS REPORTED TO BE FINE FOLLOWING THE PROCEDURE. THE FACILITY ADDRESS, DEVICE LOT NUMBER, AND PHYSICIAN CONTACT INFORMATION WERE ALSO PROVIDED.

  Patient problems: Hematuria; Urinary Retention

  MAUDE report 20850557 ↗
• InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, NEOTRACT HAS BEEN MADE AWARE BY A [PHYSICIAN] THAT ¿TWO PATIENTS WHO UNDERWENT THE PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON OCTOBER 31, 2024, REQUIRED READMISSION TO THE HOSPITAL DUE TO HEMATURIA AND CLOT RETENTION. ACCORDING TO [PHYSICIAN], ONE PATIENT REQUIRED A RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. [PHYSICIAN] NOTED THAT BLEEDING EVENTS OF THIS NATURE ARE NOT UNCOMMON FOLLOWING BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURES.¿ ON (B)(6) 2024, A LABEL PHOTO OF THE DEVICE WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 12, 2024, INDICATED THAT ONE OF THE PATIENTS EXPERIENCED HEMATURIA AND CLOT RETENTION IN THE EVENING FOLLOWING THE UROLIFT PROCEDURE. THE PATIENT HAD ALREADY BEEN ADMITTED TO THE HOSPITAL AT THAT TIME AND UNDERWENT CLOT EVACUATION SURGERY. POST-SURGERY, THE PATIENT WAS REPORTED TO BE FINE. THE FACILITY ADDRESS, DEVICE LOT NUMBER, AND PHYSICIAN CONTACT INFORMATION WERE ALSO PROVIDED.

  Patient problems: Hematuria; Urinary Retention

  MAUDE report 20850547 ↗