UROLIFT IPN056885Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10814932020206), received between Jul 11, 2022 and Nov 21, 2025 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2025Firing Problem; Firing Problem

  IT WAS REPORTED " DID NOT FIRE CORRECTLY". ADDITIONAL INFOMATION STATES THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "DOING WELL" VIA THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 23616973 ↗
• MalfunctionJun 23, 2025Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT "DR.(B)(6) DEPLOYED THE FIRST IMPLANT, AFTER THE THIRD PULL, THE CAPSULAR TAB WAS IN THE KEYHOLE. I BELIEVE IT IS A PARTIAL CAPSULAR TAB PULL THROUGH".THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307196 ↗
• InjuryMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, NEO TRACT RECEIVED INFORMATION FROM A LITERATURE ARTICLE PUBLISHED IN EUROPEAN UROLOGY ON (B)(6) 2023 ABOUT A 68-YEAR-OLD PATIENT WHO UNDERWENT A PROSTATIC URETHRAL LIFT. THE PROCEDURE WAS UNEVENTFUL, AND POST-PROCEDURE IN RECOVERY, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE DROPPED TO 70MMHG, WHICH WAS MANAGED BY HYDRATION AND LEG ELEVATION. HIS HEMOGLOBIN LEVEL HAD ALSO DECREASED TO 11.8 G/DL FROM A BASELINE OF 14.4 G/DL. HE WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. ON POSTOPERATIVE DAY 6, A CT SCAN REVEALED A 238-CM3 HEMATOMA IN THE LEFT PELVIC CAVITY THE PELVIC HEMATOMA IS DRAINED SURGICALLY ACCORDING TO THE PATIENT'S PREFERRED POLICY.

  Patient problems: Hematoma; Low Blood Pressure/ Hypotension

  MAUDE report 18914960 ↗
• MalfunctionFeb 1, 2023Fracture; Fracture

  ON 1 DECEMBER 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 DURING THE PROCEDURE, ONE DEVICE DID NOT SUCCESSFULLY DEPLOY AN IMPLANT. DURING THE INVESTIGATION OF THE RETURNED DEVICE ON 6 JANUARY 2023, IT WAS NOTED THAT AN APPROXIMATELY 6 MM SECTION OF THE TAIL OF THE CT WAS BROKEN AND MISSING FROM THE RETURNED DEVICE. THE PHYSICIAN WAS NOTIFIED, AND ON (B)(6) 2023, AN X-RAY REVEALED THAT NO PORTION OF THE CT REMAINED IN THE PATIENT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281310 ↗
• MalfunctionJan 12, 2023Fracture; Fracture

  ON (B)(6) 2022, 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. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2022 REVEALED THAT APPROXIMATELY 1MM OF THE NEEDLE WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION RESULTS AND CONFIRMED THAT A CYSTOSCOPY WAS PERFORMED AND THERE WAS NO EVIDENCE OF A BROKEN NEEDLE FRAGMENT REMAINING IN THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151724 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 24 OCTOBER 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PROPERLY DEPLOY THE IMPLANT AND REMOVED THE DEVICE FROM THE SHEATH WITH THE IMPLANT STILL ATTACHED TO THE DELIVERY HANDLE. UPON REMOVAL, TEARING OF THE PROSTATE WAS NOTED, REQUIRING THULIUM VAPORIZATION OF THE PROSTATE AND ANTIPLATELET MEDICATION TO CONTROL SIGNIFICANT BLEEDING, AND THE PATIENT¿S CONDITION WAS NOTED AS FINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15839058 ↗
• InjuryOct 7, 2022Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT WAS PERFORMED ON THAT DAY. DURING THE PROCEDURE, IT WAS REPORTED THAT AS THE PHYSICIAN REMOVED THE DEVICE FROM THE SHEATH, A METAL PIECE OF THE DEVICE¿S SHAFT CUT THE GLOVE AND HAND OF THE PHYSICIAN CAUSING A PUNCTURE TO HIS SKIN. IT WAS REPORTED THAT THE PHYSICIAN RECEIVED A "PREVENTATIVE BLOODWORK ANALYSIS RIGHT AFTER THE CASE". INVESTIGATION OF THE RETURNED DEVICE ON 4 OCTOBER 2022 REVEALED ONE OF THE TAB FEATURES OF THE SHAFT WAS BENT AND OUT OF SPECIFICATION, HOWEVER THE CAUSE OF THE BENT TAB WAS UNKNOWN. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 15567766 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22 JULY 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 THE PATIENT STARTED A BLOOD THINNER ONE DAY POST-PROCEDURE AND DEVELOPED PAIN, FEVER, SYNCOPE, AND A HEMATOMA. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FIVE DAYS AND EXPERIENCED AN EPISODE OF SYNCOPE. THE PHYSICIAN REPORTED THAT AS OF (B)(6) 2022, THE HEMATOMA HAD PARTIALLY RESOLVED. NO ADDITIONAL INFORMATION ABOUT THE PATIENT WAS AVAILABLE.

  Patient problems: Hematoma; Pain; Syncope/Fainting

  MAUDE report 15259726 ↗
• MalfunctionAug 17, 2022Fracture; Fracture

  ON 19 JULY 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY DEPLOY ONE OF THE IMPLANTS. UPON REMOVAL OF THE DELIVERY DEVICE FROM THE PATIENT, THE PHYSICIAN NOTED THAT THE NEEDLE WAS BROKEN AND REMOVED THE BROKEN PORTION FROM THE PATIENT¿S BODY. HE CONFIRMED THE ENTIRE NEEDLE WAS ACCOUNTED FOR AFTER A THOROUGH INSPECTION. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15246390 ↗
• MalfunctionJul 11, 2022Fracture; Fracture

  ON 13 JUNE 2022, NEOTRACT BECAME AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. IT WAS REPORTED THAT AFTER PLACING THE IMPLANT, A PORTION OF THE NEEDLE WAS VISUALIZED IN THE PATIENT. THE NEEDLE AND IMPLANT WERE REMOVED WITH FORCEPS, AND IT WAS REPORTED THE ENTIRE NEEDLE WAS REMOVED FROM THE PATIENT. THE DEVICE HAS NOT BEEN INVESTIGATED BY NEOTRACT AT THIS TIME. THE PATIENT WAS REPORTED TO HAVE RECEIVED A CATHETER AND DID NOT EXPERIENCE ANY ADVERSE EVENTS RELATED TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14982765 ↗