UROLIFT IPN056134Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10814932020121), received between Jul 11, 2022 and Sep 15, 2025 — classified as 1 death, 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Ejection Problem; Ejection Problem

  IT WAS REPORTED "WHEN PLACING THE FIRST IMPLANT ON THE LEFT BLADDER NECK, THE USER PULLED THE TRIGGER OF THE HANDLE 4 TIMES, BUT THE IMPLANT COULDN'T BE PLACED. THE DEVICE WAS REMOVED FROM THE BODY AND CHECKED. THE DEVICE HAD NOT WORKED SINCE THE NEEDLE WAS HALFWAY OUT (AFTER PULL 2). THE HANDLE DID NOT MOVE, AND THE CARTRIDGE COULD NOT BE REMOVED".THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23050397 ↗
• MalfunctionJul 16, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT "WORKED A CASE WITH A DOCTOR WHERE WE HAD TWO UNSUCCESSFULL IMPLANTS IN A ROW. ON THE FIRST ONE IT LOOKED LIKE THERE WAS MEDAL IN THE KEYHOLE SO I THOUGHT IT MIGHT HAVE BEEN A CAPSULAR TAP PULL THROUGH BUT THE GLAND WAS QUITE SMALL AND THE DOCTOR HAD GOOD TECHNIQUE. SO ASKED THE DOCTOR TO DO MORE COMPRESSION AFTER THE FIRST PULL ON THE SECOND IMPLANT AND WE HAD ANOTHER MISFIRE. DOCTOR SAID THEY BOTH FELT WEIRD, AND I THOUGHT HE HAD GOOD TECHNIQUE ON BOTH AND WAS SURPRISED THERE WAS NO SUTURE IN THE KEYHOLE. WE THEN OPENED A NEW HANDLE AND THE NEXT 4 IMPLANTS WENT SMOOTHLY". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519996 ↗
• MalfunctionJun 24, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT "AFTER THE PROCEDURE AND WHILE IN RECOVERY, THE PATIENT THAT RECEIVED THE UROLIFT BEGAN TO PRESENT WITH INCREASING TIGHTNESS OF THE ABDOMEN. THE PATIENT WAS ORDERED A CT, WHICH CONFIRMED A HEMATOMA IN THE PATIENT'S PELVIC AREA. AT THIS TIME, THE PATIENT'S SYMPTOMS DO NOT APPEAR TO BE WORSENING. THE PATIENT IS BEING ADMITTED OVERNIGHT FOR OBSERVATION". ADDITIONAL INFORMATION STATES THAT THE PATIENT IS NOW "DISCHARGED FROM THE HOSPITAL".

  Patient problems: Hematoma

  MAUDE report 22321490 ↗
• InjuryJun 4, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED " [PATIENT] RECEIVED 5 UROLIFT IMPLANTS IN OFFICE PROCEDURE, LEFT WITH A CATHETER IN PLACE. THE EVENING OF THE PROCEDURE THE PATIENT WAS IN THE HOSPITAL RECEIVING A BLOOD TRANSFUSION". ADDITIONAL INFORMATION STATES THAT THERE WAS NO DEVICE FAILURE. THE CUSTOMER WAS ASKED TO FURTHER CLARIFY THE EVENTS SURROUNDING THE BLOOD TRANSFUSION REPORTED, THE CUSTOMER STATES THAT THE PATIENT EXPERIENCED A HEMATOMA AND SEVERE BLEEDING. THE CURRENT CONDITION OF THE PATIENT IS REPORTED AS "STABLE AT HOME AND VOIDING".

  Patient problems: Insufficient Information

  MAUDE report 22144783 ↗
• MalfunctionApr 29, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT "CIRCULATOR OPENED THE UL2-C PRODUCT, THERE WAS A DEAD BUG AND LOOKED LIKE A POD INSIDE THE STERILE CONTAINER ONCE OPENED. DR.(B)(6) SAID THAT HE WOULD NOT USE IT IN A PATIENT AND ASKED TO OPEN A NEW PRODUCT. NEW PRODUCT WAS USED AND CASE WAS COMPLETED WITHOUT ANY PROBLEMS TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21927026 ↗
• DeathJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 16 JUNE 2023, NEOTRACT BECAME AWARE OF A PATIENT WITH A HISTORY OF ANEMIA AND ANTICOAGULANT USE WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2023. THE NIGHT OF THE PROCEDURE, THE PATIENT WAS ADMITTED TO THE HOSPITAL, DIAGNOSED WITH A HEMATOMA, AND REQUIRED A BLOOD TRANSFUSION. IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2023 DUE TO ACUTE MYELOID LEUKEMIA.

  Patient problems: Cancer; Hematoma

  MAUDE report 17312425 ↗
• MalfunctionSep 16, 2022Fracture; Fracture

  ON 19 AUGUST 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTED THAT TWO DEVICES FAILED TO SUCCESSFULLY DELIVER AN IMPLANT. ON 19 AUGUST 2022, INVESTIGATION OF ONE RETURNED DEVICE FOUND THAT APPROXIMATELY 1.0 MM OF THE NEEDLE TIP WAS DAMAGED AND MISSING. ON 25 AUGUST 2022 WE RECEIVED ADDITIONAL INFORMATION THAT THE PHYSICIAN DID NOT RECALL SEEING ANY FRAGMENTS OF THE NEEDLE DURING INSPECTION POST PROCEDURE AND STATED THAT HE DID NOT PLAN ON TAKING ANY ADDITIONAL STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15442861 ↗
• MalfunctionAug 19, 2022Fracture; Fracture

  ON 22 JUNE 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT THERE WAS AN UNUSUAL NOISE DURING THE PROCEDURE. ON 22 JULY 2022, INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT A NEEDLE FRAGMENT WAS MISSING. ON 17 AUGUST 2022, NEOTRACT RECEIVED ADDITIONAL INFORMATION THAT THE MISSING NEEDLE FRAGMENT HAD BEEN REMOVED FROM THE PATIENT AND DISPOSED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED, AND NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259757 ↗
• MalfunctionAug 10, 2022Break; Break

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON THAT DAY. THE PHYSICIAN REPORTED THAT THE IMPLANT COULD NOT BE DEPLOYED AND THE DEVICE WAS REMOVED WITH A PORTION OF THE NEEDLE EXPOSED. IT WAS REPORTED THAT SINCE THE NEEDLE WAS EXPOSED DURING THE REMOVAL, SOME URETHRAL TRAUMA OCCURRED. THE PATIENT EXPERIENCED URETHRAL TEARING AND ADDITIONAL BLEEDING, WHICH WAS MANAGED BY CATHETERIZATION. UPON ATTEMPTING TO REMOVE THE IMPLANT CARTRIDGE FROM THE DELIVERY HANDLE, THE PHYSICIAN ENCOUNTERED RESISTANCE, WHICH LED TO ADDITIONAL DAMAGE TO THE DELIVERY HANDLE AND NEEDLE AFTER IT WAS REMOVED AND OCCURRING OUTSIDE THE PATIENT. NO OTHER INTERVENTIONS WERE PERFORMED AND IT WAS REPORTED THAT THE PATIENT¿S CONDITION WAS FAIR.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15204930 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 20 APRIL 2022, NEOTRACT WAS NOTIFIED ABOUT A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNSPECIFIED DATE. AFTER THE PROCEDURE, THE PATIENT PRESENTED WITH BRUISING ON THE PELVIS, SCROTUM, AND PENIS. ON 25 APRIL 2022, IT WAS REPORTED THAT DURING A VISIT TO THE UROLOGIST ON (B)(6) 2022 THE HEMATOMA WAS RESOLVING ON ITS OWN AND DID NOT REQUIRE INTERVENTION. ON 13 JUNE 2022 IT WAS REPORTED THAT THE REMAINING HEMATOMA WAS DRAINED (B)(6) 2022. THE PATIENT WAS REPORTED AS DOING FINE WITH EXPECTED IRRITATION FROM THE PROCEDURE AND CONTINUED IMPROVEMENT.

  Patient problems: Hematoma

  MAUDE report 14983146 ↗