UROLIFT IPN056625Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10814932020152), received between Dec 17, 2020 and Mar 16, 2023 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K193269); they may or may not involve this specific model.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 20 JANUARY 2023, NEOTRACT WAS MADE AWARE OF A PATIENT THAT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE THAT DAY. DURING THE PROCEDURE, IT WAS NOTED THAT ONE IMPLANT DID NOT TENSION AND WAS REMOVED WITH GRASPERS. IT WAS REPORTED TO NEOTRACT ON 16 FEBRUARY 2023, THAT SOMETIME WITHIN ONE DAY OF THE PUL PROCEDURE, THE PATIENT WENT INTO KIDNEY FAILURE AND WAS HOSPITALIZED FOR THREE DAYS. A CYSTOSCOPY REVEALED THAT THE PATIENT'S URETERS WERE "VERY DISTAL/CLOSE TO THE BLADDER NECK" AND WERE "CLOSED OFF/OCCLUDED." IT WAS REPORTED THAT THE TENSION CAUSED BY OPENING THE PROSTATIC LATERAL LOBES WITH UROLIFT IMPLANTS CAUSED THE URETERS TO BECOME TAUT AND OCCLUDED AND BILATERAL STENTS WERE PLACED. THE PATIENT WAS REPORTED TO BE VOIDING WELL AND THE PHYSICIAN PLANS ON REMOVING THE STENTS ONE AT A TIME.

  Patient problems: Renal Failure

  MAUDE report 16559892 ↗
• MalfunctionSep 1, 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 SIX DEVICES DID NOT PROPERLY DEPLOY THE IMPLANT. IT WAS REPORTED THAT THEY APPEARED TO FAIL AS A RESULT OF PATIENT ANATOMY. INVESTIGATION OF ONE OF THE RETURNED DEVICES ON 2 AUGUST 2022 IDENTIFIED THAT A 2MM NEEDLE FRAGMENT WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND REPORTED THAT HE REMOVED THE NEEDLE FRAGMENT IMMEDIATELY DURING THE CASE. NO PATIENT ADVERSE EVENTS WERE REPORTED, AND THE PATIENT WAS REPORTED AS HAVING NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15341875 ↗
• MalfunctionMay 6, 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, IT WAS NOTED THAT ONE DEVICE MADE AN UNUSUAL NOISE DURING AN OTHERWISE SUCCESSFUL DEPLOYMENT. IT WAS REPORTED THAT AFTER DEPLOYMENT AND REMOVAL FROM THE PATIENT, THE DEVICE COULD NOT BE DETACHED FROM THE SHEATH. ON (B)(6) 2022, INVESTIGATION OF THE RETURNED DEVICE AND SHEATH CONFIRMED THAT A PORTION OF THE DEVICE HAD BEEN DAMAGED WITH A PORTION STUCK WITHIN THE SHEATH. WHILE SOME MATERIAL WAS UNACCOUNTED FOR, IT WAS ALSO UNCLEAR IF THE DAMAGE OCCURRED DURING THE PROCEDURE OR AFTER THE SHEATH WAS REMOVED FROM THE PATIENT. THE PHYSICIAN WAS NOTIFIED AND CONFIRMED THAT HE DID AN EXAMINATION FOLLOWING COMPLETION OF THE PROCEDURE TO ENSURE THAT NO PORTION OF THE DEVICE WAS STILL IN THE PATIENT AND DID NOT FEEL ANY FOLLOW UP WAS NECESSARY. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14296839 ↗
• MalfunctionDec 29, 2021Fracture; Fracture

  ON (B)(4) 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 TWO IMPLANTS DID NOT SUCCESSFULLY DEPLOY. ON (B)(6) 2021, DURING THE DEVICE INVESTIGATION IT WAS NOTED THAT APPROXIMATELY 35MM OF THE NEEDLE TIP WAS UNACCOUNTED FOR ON ONE DEVICE. ON (B)(6) 2021, THE PHYSICIAN CONFIRMED THAT HE DID NOT VISUALIZE ANY NEEDLE FRAGMENTS DURING THE TIME OF THE PROCEDURE, AND HE WILL FOLLOW UP WITH THE PATIENT TO MAKE SURE HE IS DOING WELL. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114561 ↗
• MalfunctionNov 22, 2021Fracture; Fracture

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, IT WAS NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY CAUSING THE CAPSULAR TAB TO BREAK. ON (B)(6) 2021, RETURNED DEVICE ANALYSIS CONFIRMED THAT A 0.25 INCH FRAGMENT WAS MISSING FROM THE CAPSULAR TAB. THE PHYSICIAN WAS INFORMED AND STATED THAT NO ADDITIONAL SCANNING WILL BE PERFORMED AND THE FRAGMENT WAS LIKELY FLUSHED OUT DURING THE PROCEDURE. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858433 ↗
• MalfunctionNov 2, 2021Fracture; Fracture

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO UNDERWENT A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT ONE IMPLANT DID NOT SUCCESSFULLY DEPLOY AND PHYSICIAN REPORTED THAT IT APPEARED A PORTION OF THE NEEDLE HAD DISCONNECTED FROM THE DEVICE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DETACHED NEEDLE, BUT DUE TO POOR VISIBILITY COULD NOT CONFIRM THE NEEDLE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ASSESSED THE BLADDER UNDER FLUOROSCOPY AND FOUND NO RADIOGRAPHIC EVIDENCE OF THE DETACHED NEEDLE. ON (B)(6) 2021, DURING INVESTIGATION OF THE RETURNED DEVICE, IT WAS NOTED THAT APPROXIMATELY 20MM OF THE NEEDLE TIP WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN STATED HE WOULD REEXAMINE THE PATIENT USING CYSTOSCOPY. IT WAS REPORTED THAT THE PATIENT WAS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12737505 ↗
• MalfunctionOct 12, 2021Fracture; Fracture

  ON 28 JULY 2021, NEOTRACT WAS MADE AWARE OF A DEVICE THAT FAILED TO DEPLOY AN IMPLANT DURING A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL). ON (B)(6) 2021, UPON INVESTIGATION OF THE DEVICE, IT WAS DETERMINED THAT APPROXIMATELY 35MM OF THE NEEDLE WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND HE STATED THAT NO NEEDLE FRAGMENT WAS LEFT IN THE PATIENT. AS A RESULT, NO PATIENT FOLLOW UP WAS PLANNED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616020 ↗
• MalfunctionDec 17, 2020Fracture; Fracture

  ON 27 OCTOBER 2020, NEOTRACT WAS MADE AWARE OF A PHYSICIAN THAT EXPERIENCED MULTIPLE DELIVERY DEVICES THAT DID NOT PROPERLY DEPLOY DURING THE PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ADDITIONAL DEVICES. ON (B)(6) 2020, NEOTRACT'S DEVICE ANALYSIS INDICATED THAT ONE OF THE RETURNED DEVICES WAS MISSING APPROXIMATELY 2MM OF THE NEEDLE TIP. NEOTRACT NOTIFIED THE PHYSICIAN OF THE INVESTIGATION RESULTS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11029381 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193269. One submission often covers many models, so check the product and lot details in each record.

• Z-1502-2022 · Jun 24, 2022 · Open, Classified
  UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool