UROLIFT IPN923352Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10814932020299), received between Oct 4, 2022 and Sep 5, 2023 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 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 NOTICED THAT THE NEEDLE WAS EXPOSED WHILE OPENING THE IMPLANT PACKAGE. IT WAS REPORTED THAT THE DEVICE WAS NOT USED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM OR INJURY. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023 CONFIRMED THAT APPROXIMATELY .86MM OF THE NEEDLE TIP WAS BROKEN AND UNACCOUNTED FOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686783 ↗
• MalfunctionMay 3, 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. INVESTIGATION OF THE RETURNED DEVICE ON 17 APRIL 2023 CONFIRMED THAT APPROXIMATELY 1.5MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED OF THE BROKEN NEEDLE; HOWEVER, THE PHYSICIAN DID NOT DISCLOSE THEIR NEXT STEPS. THERE WAS NO PATIENT HARM OR INJURY REPORTED AT THE TIME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862700 ↗
• InjuryMar 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 14 FEBRUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2023. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED AND ADMITTED INTO THE HOSPITAL FOR BLEEDING. APPROXIMATELY TWO DAYS LATER, THE PATIENT HAD AN ¿OPEN PROCEDURE¿ TO REPAIR DORSAL VENOUS BLEEDING. ON AN UNSPECIFIED DATE, THE PATIENT WAS DISCHARGED. NO ADDITIONAL INFORMATION ABOUT THE PATIENT WAS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16541950 ↗
• MalfunctionMar 10, 2023Fracture; Fracture

  ON 19 JANUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2023. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. INVESTIGATION OF THE RETURNED DEVICE ON 8 FEBRUARY 2023 CONFIRMED THAT APPROXIMATELY 27MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN STATED THAT NO FURTHER FOLLOW-UP ACTION WAS PLANNED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527050 ↗
• InjuryMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2023. FOLLOWING THE PROCEDURE, A CATHETER WAS PLACED. IT WAS REPORTED THE PATIENT WAS LATER DIRECTED TO THE ER DUE TO DIFFICULTIES FLUSHING THE CATHETER. THERE HE WAS FOUND TO BE IN HYPERTENSIVE CRISIS, FLASH PULMONARY EDEMA, AND CARDIAC FAILURE AND WAS ADMITTED TO THE HOSPITAL UNTIL (B)(6) 2023 WHEN HE WAS DISCHARGED HOME. THE PHYSICIAN STATED THE PROBLEMS WERE RELATED TO THE PATIENT¿S PREVIOUS CONDITION OF BLOOD THINNER USE AND NOT RELATED TO THE PUL PROCEDURE. THE PHYSICIAN DOES NOT PLAN FOR ANY FOLLOW UP ACTIONS AND THE PATIENT¿S CONDITION IS NOTED AS FINE.

  Patient problems: Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 16526547 ↗
• MalfunctionMar 10, 2023Fracture; Fracture

  ON 8 FEBRUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. INVESTIGATION OF THE RETURNED DEVICE ON 8 FEBRUARY 2023 CONFIRMED THAT APPROXIMATELY 1.5MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN STATED THAT NO FURTHER FOLLOW-UP ACTION WAS PLANNED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526531 ↗
• MalfunctionMar 10, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2023 CONFIRMED THAT APPROXIMATELY 1MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN STATED THAT NO FURTHER FOLLOW-UP ACTION WAS PLANNED. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526525 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  ON 12 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 NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY ONE OF THE IMPLANTS. PART OF THE IMPLANT AND A "SMALL METAL" PIECE INSIDE THE BLADDER WERE BOTH REMOVED USING FLEXIBLE GRASPERS. INVESTIGATION OF THE RETURNED DEVICE ON 24 JANUARY 2023 CONFIRMED THAT APPROXIMATELY 1.5MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR, BUT THE PHYSICIAN WAS CONFIDENT THE NEEDLE TIP WAS REMOVED FROM THE PATIENT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16429654 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 10 JANUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. AFTER THE PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS ABLE TO VOID WITH NO HEMATURIA, BUT LATER BECAME HYPOTENSIVE AND WAS GIVEN FLUIDS. WHILE STILL IN THE HOSPITAL, THE PATIENT CODED AND WAS REVIVED. THE PATIENT WAS FOUND TO HAVE A BLEED REQUIRING EMBOLIZATION AND A BLOOD TRANSFUSION. IT WAS REPORTED THAT FOLLOWING THAT PROCEDURE, THE PATIENT REQUIRED AN ADDITIONAL BLOOD TRANSFUSION AND POTENTIALLY ANOTHER PROCEDURE. THE PATIENT STATUS IS UNKNOWN AND NO FURTHER FOLLOW UP HAS BEEN RECEIVED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 16309182 ↗
• 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 1MM OF THE NEEDLE WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION AND THE RESPONSE IS STILL PENDING. HOWEVER, THERE WAS NO PATIENT HARM OR INJURY REPORTED AT THE TIME OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16151619 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT WAS PERFORMED ON THAT DAY. NO COMPLICATIONS WERE NOTED DURING THE CASE. IT WAS REPORTED THAT WHILE CHANGING THE WASTE AFTER THE PROCEDURE, ONE OF THE MEDICAL STAFF WAS PRICKED BY AN EXPOSED NEEDLE THAT WAS IN THE TRASH RECEPTACLE. THE STAFF MEMBER RECEIVED A BLOOD WORK AFTER THE CASE. NO ADDITIONAL INFORMATION WAS REPORTED FOR THE STAFF MEMBER, AND THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 16053505 ↗
• MalfunctionDec 21, 2022Fracture; Fracture

  ON (B)(6) 2022, 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 A DEVICE DID NOT PROPERLY DEPLOY TWO IMPLANTS. INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2022 CONFIRMED THAT 1MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND STATED HE DID A THROUGH CYSTOSCOPY AFTER THE PROCEDURE AND WAS NOT CONCERNED THAT A FRAGMENT WAS LEFT BEHIND IN THE PATIENT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16020259 ↗
• InjuryNov 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28 OCTOBER 2022, NEOTRACT WAS MADE AWARE OF PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. NO COMPLICATIONS WERE REPORTED AT THE PROCEDURE. IT WAS LATER REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL ON (B)(6) WITH SEVERE BLEEDING. THE PATIENT WAS TREATED FOR BLEEDING BY VAPORIZATION AND CAUTERIZATION OF TISSUE IN THE PROSTATE, AND THE BLEEDING WAS CONTROLLED. THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING FINE AND HAS HAD NO OTHER PROBLEMS.

  Patient problems: Hematuria

  MAUDE report 15866677 ↗
• MalfunctionOct 26, 2022Fracture; Fracture

  ON 27 SEPTEMBER 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 NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT. IT WAS NOTED THAT THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT AND NO PATIENT ADVERSE EVENTS WERE REPORTED. INVESTIGATION OF THE RETURNED DEVICE ON 27 SEPTEMBER 2022 CONFIRMED THAT 15MM OF THE NEEDLE WAS UNACCOUNTED FOR. REPEATED ATTEMPTS TO CONTACT THE PHYSICIAN REGARDING THE NEEDLE FRAGMENT WERE UNSUCCESSFUL. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15677795 ↗
• MalfunctionOct 4, 2022Fracture; Fracture

  ON (B)(6) 2022, 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. IT WAS NOTED DURING THE PROCEDURE THAT THE TIP OF THE NEEDLE APPEARED DAMAGED AND CONCLUDED THAT THE ISSUE WAS LIKELY DUE TO PATIENT ANATOMY. INVESTIGATION OF THE RETURNED DEVICE ON 6 SEPTEMBER 2022 CONFIRMED THAT 17 MM OF THE NEEDLE WAS BROKEN BUT WAS INCLUDED WITH THE RETURNED DEVICE, AND THE ENTIRE LENGTH OF THE NEEDLE WAS ACCOUNTED FOR. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15541290 ↗