UROLIFT IPN055826Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00814932020087), received between Dec 17, 2020 and Dec 2, 2025 — classified as 3 injuries, 12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED "UPON PLACEMENT OF THE FIRST IMPLANT, A BONE CONTACT WAS PRESUMED TO HAVE OCCURRED. THE NEEDLE COULD BE SEEN IN THE WINDOW, HE PERFORMED THE CONTRALATERAL MANEUVRE, FOLLOWED BY RE-COMPRESSION AND LEVER RETRACTION. HOWEVER, NO SUTURE WAS VISIBLE IN THE WINDOW. FOLLOWING THIS, HE TRIED TO UNLOCK THE DEVICE FROM THE SCOPE FOR REMOVAL, BUT THE BLUE CONNECTOR BROKE OFF. HE NEEDED TO USE A TOOL TO HELP TURN THE LOCK MANUALLY". 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 23696697 ↗
• InjuryOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED "PERFORMED THE FIRST TWO IMPLANTS ASPER IFU STEPS, WITH SUCCESS. "HOWEVER UPON" VISUALISATION, WE COULD SEE "THAT THERE" WAS A LONG STRAND OF BLUE "SUTURE HANGING" FROM THE URETHRAL END PIECE. "THE IMPLANTS' WERE OTHERWISE SATISFACTORY, VERY WELL INVAGINATED INTO THE TISSUE. THE SURGEON IMPLANTED 3 MORE DEVICES, WITH SUCCESS. WHEN HE DID ONE "LAST VISUAL" CHECK OF THE BLADDER, "UPON VISUALISATION", WE SAW A SHINY FLAKE "OF WHAT" APPEARED TO BE METAL, FLOATING "IN THE" BLADDER. THIS FLAKE WAS NOT A "URETHRAL END" PIECE OR CAPSULAR TAB". 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 23293133 ↗
• MalfunctionSep 8, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT " DURING THE PROCEDURE, THE SUTURE WAS NOT VISIBLE. CONSEQUENTLY, THE DEVICE WAS REMOVED, AND THE CASE WAS PROCEEDED WITH A NEW DEVICE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991027 ↗
• MalfunctionSep 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "DURING THE PROCEDURE, THE SUTURE WAS NOT VISIBLE. CONSEQUENTLY, THE DEVICE WAS REMOVED, AND THE CASE WAS PROCEEDED WITH A NEW DEVICE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22991010 ↗
• MalfunctionAug 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED " DURING THE PROCEDURE, AN ISSUE OCCURRED IN WHICH THE SUTURE WAS NOT VISIBLE, AND THE NEEDLE RETRACTED BACK INTO THE DEVICE. AS A RESULT, THE CASE WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT ADVERSE EVENT DUE TO THIS ISSUE, AND THE PATIENT'S CONDITION IS FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840591 ↗
• MalfunctionJul 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT " WHEN INSERTING THE FIRST TWO IMPLANTS, ALTHOUGH THE SURGEON PRESSED THE BLUE AND GRAY TRIGGERS, THE BLUE SUTURE THREAD WAS NOT VISIBLE IN THE KEYHOLE.IT APPEARED THAT THE CAPSULAR TAB WAS NOT DEPLOYED INTO THE PROSTATE CAPSULE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608786 ↗
• MalfunctionJul 25, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT "DESCRIPTION OF THE INCIDENT: THIS INTRAPROSTATIC IMPLANT WAS NOT DELIVERED BY UROLIFT DEVICE. ANOTHER IMPLANT WAS USED". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608588 ↗
• MalfunctionJul 24, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT " DURING INSERTION (IT WAS THE THIRD IMPLANT), ALTHOUGH THE SURGEON PRESSED THE BLUE AND GREY TRIGGERS, THE BLUE SUTURE WAS NOT VISIBLE IN THE KEYHOLE. IT APPEARED THAT THE CAPSULAR TAB HAS NOT BEEN DEPLOYED IN THE PROSTATIC CAPSULE. THE SURGEON IS ASKING FOR VERIFICATION THAT THE CAPSULAR TAB IS STILL IN THE DEVICE AND NOT DROPPED INTO THE PROSTATE. IT WAS NOT A MEDIAN LOBE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22586631 ↗
• MalfunctionJul 3, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT "DURING PROCEDURE, AN ISSUE OCCURRED WHERE THE SUTURE WAS NOT VISIBLE, AND THE NEEDLE RETRACTED BACK INTO THE DEVICE. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE". THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

  Patient problems: Insufficient Information

  MAUDE report 22396915 ↗
• InjuryMar 7, 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 THAT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT APPROXIMATELY SIX WEEKS POST PROCEDURE, THE PATIENT BEGAN EXPERIENCING URINARY SYMPTOMS AND PAIN. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY DIAGNOSED WITH AN INFECTION THAT TRAVELED TO THE PATIENT¿S BLOOD STREAM. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS FOR APPROXIMATELY SIXTEEN WEEKS, WHICH CLEARED THE INFECTION. THE PATIENT CONTINUES TO EXPERIENCE URINARY SYMPTOMS AND IS TAKING ORAL MEDICATION TO ADDRESS THE CONTINUED SYMPTOMS.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 16499810 ↗
• MalfunctionSep 23, 2022Fracture; Fracture

  ON 1 AUGUST 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. ON 24 AUGUST 2022 INVESTIGATION REVEALED A MISSING PORTION OF THE NEEDLE TIP. ADDITIONAL INFORMATION RECEIVED ON 5 SEPTEMBER 2022 REPORTED THAT THE PHYSICIAN DIDN¿T SEE ANY FRAGMENTS DURING THE PROCEDURE AND PLANNED TO EXAMINE THE PATIENT WITH X-RAY DURING THE NEXT FOLLOW UP VISIT. NO ADVERSE EVENTS WERE REPORTED AND THE CURRENT STATUS OF THE PATIENT WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15473463 ↗
• MalfunctionFeb 8, 2022Fracture; Fracture

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO HAD RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY DEPLOY ONE OF THE IMPLANTS AND REMOVED THE DELIVERY DEVICE FROM THE PATIENT. THE PHYSICIAN NOTED THAT THE NEEDLE WAS BROKEN AND DETACHED FROM THE DEVICE, BUT CONFIRMED THAT THE ENTIRE NEEDLE WAS ACCOUNTED FOR BY INSPECTING THE DEVICE AND PATIENT. FURTHER INSPECTION BY NEOTRACT CONFIRMED THAT 20MM OF THE NEEDLE WAS BROKEN, BUT THAT THE ENTIRE NEEDLE WAS ACCOUNTED FOR. THE PROCEDURE WAS COMPLETED AND NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13482607 ↗
• MalfunctionDec 16, 2021Fracture; Fracture

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT ONE IMPLANT DID NOT SUCCESSFULLY DEPLOY. ON 17 NOVEMBER 2021, DURING THE DEVICE INVESTIGATION IT WAS NOTED THAT APPROXIMATELY 33MM OF THE NEEDLE TIP WAS UNACCOUNTED FOR. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13023277 ↗
• MalfunctionNov 11, 2021Fracture; Fracture

  ON 14 SEPT 2021, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT ONE IMPLANT DID NOT SUCCESSFULLY DEPLOY. ON (B)(6) 2021, DURING THE DEVICE INVESTIGATION IT WAS NOTED THAT APPROXIMATELY 32MM OF THE NEEDLE TIP WAS RETURNED WITH THE DEVICE BUT HAD BECOME DISCONNECTED FROM THE DEVICE. NO PORTION OF THE NEEDLE WAS UNACCOUNTED FOR. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801162 ↗
• InjuryDec 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 18 NOVEMBER 2020, NEOTRACT BECAME AWARE OF A CASE STUDY ARTICLE. PRIOR TO A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE, A (B)(6) PATIENT UNDERWENT IMPLANTATION OF AN INFLATABLE PENILE PROSTHESIS (IPP) FOR ERECTILE DYSFUNCTION AND FAILED TO RESPOND TO BPH MEDICATION THERAPY. EIGHTEEN MONTHS AFTER IPP IMPLANTATION, HE UNDERWENT A PUL PROCEDURE USING SEVEN IMPLANTS. TWO WEEKS POST PROCEDURE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED IMPROVED BPH SYMPTOMS AND OUTCOMES TWO MONTHS POST PROCEDURE, THE PATIENT EXPERIENCED IPP MALFUNCTION REQUIRING SUBSEQUENT REMOVAL AND A REPLACEMENT PROCEDURE. THE AUTHORS HYPOTHESIZED THAT THE NEEDLE FROM THE PUL DELIVERY DEVICE MAY HAVE PUNCTURED THE IPP RESERVOIR DURING DEPLOYMENT. THERE WAS NO ADDITIONAL INFORMATION REGARDING THE PATIENT¿S CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 11028993 ↗