UROLIFT IPN056288Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10814932020145), received between Oct 2, 2020 and Mar 9, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 9, 2023Fracture; Fracture

  ON (B)(6) 2023, NEOTRACT WAS MADE AWARE OF A PATIENT WHO RECEIVED A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE ON (B)(6) 2022. APPROXIMATELY TEN MONTHS POST PROCEDURE, THE PATIENT RETURNED TO HIS PHYSICIAN DUE TO THE RETURN OF IRRITATIVE SYMPTOMS THAT INCLUDED URGENCY AND FREQUENCY. THE PATIENT UNDERWENT A SECOND PUL PROCEDURE ON (B)(6) 2023 AND AS THE CYSTOSCOPE WAS FIRST PLACED, AN "ENTIRE DEVICE NEEDLE AND IMPLANT WERE SEEN IN THE PATIENT PROSTATIC URETHRA". THE NEEDLE AND IMPLANT WERE SUCCESSFULLY REMOVED FROM THE PATIENT WITH STANDARD GRASPERS. THE SECOND PUL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16513127 ↗
• 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 THREE DEVICES DID NOT PROPERLY DEPLOY AN IMPLANT (ONE UROLIFT SYSTEM UL400 AND TWO UROLIFT ATC SYSTEM DEVICES). DUE TO CONTINUED OBSTRUCTION, THE CASE WAS CONVERTED INTO A TURP. THE TWO UROLIFT ATC SYSTEM DEVICES WERE RETURNED FOR INVESTIGATION. ON (B)(6) 2022, INVESTIGATION OF ONE OF THE RETURNED DEVICES CONFIRMED 1MM OF THE NEEDLE WAS BROKEN AND NOT ACCOUNTED FOR. THE PHYSICIAN WAS NOTIFIED AND REPORTED THAT THE PATIENT WAS DOING WELL AND NO FURTHER ACTION WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14296708 ↗
• MalfunctionOct 2, 2020Fracture; Fracture

  ON 17 AUGUST 2020, NEOTRACT WAS INFORMED OF A PROSTATIC URETHRAL LIFT (PUL) PROCEDURE DURING WHICH THE PHYSICIAN NOTED THAT A DEVICE APPEARED TO NOT DEPLOY PROPERLY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND NO PATIENT HARM OR INJURY WAS REPORTED. ON 2 SEPTEMBER 2020, NEOTRACT'S INVESTIGATION OF THE RETURNED DEVICE INDICATED THAT IT WAS MISSING 1-2MM OF THE NEEDLE TIP. NEOTRACT NOTIFIED THE PHYSICIAN OF THE INVESTIGATION RESULTS WHO, ON (B)(6) 2020, ACKNOWLEDGED THE MISSING NEEDLE PIECE AND STATED THAT HE DID NOT FEEL FURTHER EVALUATION WAS WARRANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10621527 ↗