UROLIFT IPN919209Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10814932020213), received between Jan 21, 2022 and May 4, 2023 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 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 (B)(6) 2023. THE DAY AFTER THE PROCEDURE, THE PATIENT WENT TO THE EMERGENCY ROOM FOR ABDOMINAL PAIN AND DISTENTION. A WORKUP IN THE EMERGENCY ROOM CONFIRMED AN ACTIVE BLEED IN THE REGION OF THE OBTURATOR ARTERY OUTSIDE THE PROSTATE CAPSULE. EMBOLIZATION WAS PERFORMED, AND THE PATIENT RECEIVED TWO UNITS OF BLOOD. THE PATIENT WAS HOSPITALIZED FOR THREE DAYS AND WAS DISCHARGED. THE PATIENT STATUS WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16869807 ↗
• MalfunctionFeb 23, 2023Fracture; Fracture

  ON 25 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 THE IMPLANT. THE PHYSICIAN NOTED AN OBJECT IN THAT PATIENT ANATOMY THAT THEY BELIEVED MAY HAVE BEEN A PORTION OF THE NEEDLE, HOWEVER, THEY WERE UNABLE TO LOCATE THE OBJECT TO REMOVE IT. THE PHYSICIAN STATED THEY WOULD PERFORM AN X-RAY AT A LATER DATE. PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE CONFIRMED THAT APPROXIMATELY 17MM OF THE NEEDLE WAS BROKEN AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT THE CONDITION OF THE PATIENT. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16430989 ↗
• MalfunctionOct 20, 2022Fracture; Fracture

  ON 21 SEPTEMBER 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON AN (B)(6) 2022. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT ONE DEVICE DID NOT PROPERLY DEPLOY THE IMPLANT LIKELY DUE TO PATIENT ANATOMY. INVESTIGATION OF THE RETURNED DEVICE ON 21 SEPTEMBER 2022 CONFIRMED THAT 2MM OF THE NEEDLE WAS AND UNACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION AND CONFIRMED HE THOROUGHLY EXAMINED THE PATIENT POST PROCEDURE AND FOUND NO EVIDENCE OF A BROKEN NEEDLE FRAGMENT. UPON FOLLOW UP, THE PATIENT HAS SHOWN MARKED IMPROVEMENTS IN HIS SYMPTOMS WITH NO ADVERSE EVENTS REPORTED. NO FURTHER DIAGNOSTIC TESTING WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642873 ↗
• MalfunctionAug 19, 2022Fracture; Fracture

  ON (B)(6) 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 ONE OF THE DEVICES DID NOT PROPERLY DEPLOY THE IMPLANT AND THE NEEDLE DID NOT RETRACT. INVESTIGATION OF THE RETURNED DEVICE ON 21 JULY 2022 IDENTIFIED THAT A 2MM NEEDLE FRAGMENT WAS MISSING AND UNACCOUNTED FOR. THE PHYSICIAN REPORTED THAT HE WOULD MONITOR THE PATIENT AND NO FURTHER ACTION WAS PLANNED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259563 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A PROSTATIC URETHRAL LIFT (PUL) ON (B)(6) 2022 WITH THE SUBJECT DEVICE. THE PHYSICIAN NOTED DURING CYSTOSCOPY PERFORMED ON (B)(6) 2022, THAT THE CYSTOSCOPY RESULTS WEREN¿T ¿AWFUL¿ AND THE PATIENT WAS ABLE TO VOID 233 CC WITH A RESIDUAL VOLUME OF 227 CC. ON (B)(6) 2022 AND (B)(6) 2022, ADDITIONAL DETAILS WERE PROVIDED BY THE PHYSICIAN AND THE PATIENT¿S WIFE, RESPECTIVELY, AS FOLLOWS. ON THE EVENING OF THE PROCEDURE, THE PATIENT PRESENTED TO THE ED FOR RETENTION AND REQUIRED A FOLEY CATHETER BE PLACED. ON (B)(6) 2022, THE CATHETER WAS REMOVED AND THE PATIENT PASSED A VOIDING TRIAL. ON (B)(6) 2022, THE PATIENT RETURNED TO THE ED WHERE A NEW CATHETER WAS PLACED AND HE WAS TREATED WITH ANTIBIOTICS FOR A UTI. THE PATIENT REPORTED ON (B)(6) 2022 HE WAS SEEN IN THE OFFICE FOR FOLLOW UP AND HAD HIS CATHETER REMOVED AND PASSED A VOID TRIAL. ON (B)(6) 2022, THE PATIENT RETURNED TO THE PHYSICIAN AND WAS TAUGHT HOW TO SELF-CATHETERIZE. LATER THAT SAME DAY, THE PATIENT REPORTEDLY VOIDED A PORTION OF AN IMPLANT AT HOME. ON (B)(6) 2022, THE PATIENT WAS DIAGNOSED WITH ANOTHER UTI AND TREATED WITH ANTIBIOTICS. THE PATIENT REPORTEDLY RETURNED TO THE ED ON (B)(6) 2022 AND (B)(6) 2

  Patient problems: Dysuria; Urinary Retention; Urinary Tract Infection

  MAUDE report 15204647 ↗
• InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 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 THREE IMPLANTS WERE NOT PROPERLY DELIVERED. ON (B)(6) 2022, IT WAS FURTHER REPORTED THAT THE PATIENT HAD TO UNDERGO PLASMA VAPORIZATION ON (B)(6) 2022 TO CONTROL BLEEDING AND REMOVE ONE IMPLANT. THE PATIENT WAS ADMITTED FOR TWO DAYS, BUT NO ADDITIONAL INTERVENTIONS WERE REQUIRED. IT WAS REPORTED THAT THE PATIENT WAS NO LONGER EXPERIENCING ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114112 ↗
• MalfunctionMay 26, 2022Fracture; Fracture

  ON (B)(6) 2022, NEOTRACT WAS MADE AWARE OF A PATIENT WHO HAD 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 (B)(6) 2022, INVESTIGATION OF ONE RETURNED DEVICE FOUND THAT A PORTION OF THE DEVICE HAD BEEN DAMAGED AND WAS NOT RETURNED WITH THE DEVICE. 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. WHEN THE PHYSICIAN WAS NOTIFIED, HE CONFIRMED THAT NO PART OF THE DEVICE WAS LEFT IN THE PATIENT AND THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14519852 ↗
• MalfunctionApr 7, 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 A DEVICE DID NOT PROPERLY DEPLOY AND THE NEEDLE DID NOT FULLY RETRACT. ON (B)(6) 2022, INVESTIGATION OF THE RETURNED DEVICE CONFIRMED 33MM OF THE NEEDLE WAS BROKEN BUT FULLY ACCOUNTED FOR. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047957 ↗
• MalfunctionJan 21, 2022Fracture; Fracture

  ON (B)(6) 2021, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A SUCCESSFUL PROSTATIC URETHRAL LIFT (PUL) PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT FIVE DEVICES DID NOT PROPERLY DEPLOY. ON (B)(6) 2021, RETURNED DEVICE ANALYSIS CONFIRMED THAT A 3MM FRAGMENT WAS MISSING FROM THE CAPSULAR TAB ON ONE DEVICE. THE PHYSICIAN WAS INFORMED AND STATED HE DID NOT PLAN ON DOING ADDITIONAL FOLLOW-UP WITH THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13322875 ↗

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