TUR Set 654301Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10887787006725), received between Mar 12, 2018 and Feb 2, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Fluid/Blood Leak

  UPDATED INFORMATION: THE PIERCING PIN HAS BEEN REPORTED LEAKING WHEN CONNECTED TO THE 1000ML AND 3000ML FLUID BAGS WHICH THEY ORDER FROM ICU MEDICAL. PREVIOUSLY, IT WAS COMMUNICATED THAT THE LEAKAGE ISSUE WAS OCCURRING AT THE BAG SPIKE END OF THE TUBING. HOWEVER, THE LEAKAGE IS ACTUALLY OCCURRING AT THE OPPOSITE END SPECIFICALLY AT THE CATHETER ADAPTER THAT CONNECTS TO THE FOLEY CATHETER. WHEN THE TUBING IS CONNECTED TO A SCOPE, THERE ARE NO ISSUES. HOWEVER, ONCE THE FLEXIBLE TUBING IS REMOVED AND THE TIP IS ATTACHED TO A FOLEY CATHETER, THE CONNECTION DOES NOT REMAIN SECURE AND EASILY SEPARATES. THIS CONNECTION FAILURE HAS RESULTED IN MULTIPLE PATIENTS BEING SOAKED WITH URINE, BOTH AT THEIR FACILITY AND IN THE HOME SETTING. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24241430 ↗
• MalfunctionJan 17, 2022Contamination; Contamination

  IT WAS REPORTED THAT AN EYELASH WAS IDENTIFIED IN THE BLADDER IRRIGATION TUBING OF A LTXFR NV TUR Y-SET. THE PACKAGE WAS SEALED PRIOR TO THE CUSTOMER FINDING THE EYELASH. THERE WAS NO PATIENT INVOLVEMENT, NO ADVERSE EVENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265971 ↗
• MalfunctionJun 20, 2019Particulates; Particulates

  ICU MEDICAL RECEIVED A USER FACILITY MEDWATCH (#MW5086789) STATING THAT WHEN CHANGING THE T-U-R TUBING, THE SPIKE TIP BROKE INTO PIECES DURING BLADDER IRRIGATION. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8719253 ↗
• MalfunctionJun 20, 2019Particulates; Particulates

  THE EVENT INVOLVED A T-U-R TUBING THAT WAS ORIGINALLY REPORTED THROUGH A VOLUNTARY MEDWATCH REPORT #MW5086789. IT WAS REPORTED THAT THE SPIKE BROKE INTO PIECES DURING BLADDER IRRIGATION. THERE WAS NO REPORT OF HUMAN HARM AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8718009 ↗
• MalfunctionJun 17, 2019Particulates; Particulates

  ICU MEDICAL RECEIVED A USER FACILITY MEDWATCH (#MW5086789) STATING THAT WHEN CHANGING THE T-U-R TUBING, THE SPIKE TIP BROKE INTO PIECES DURING BLADDER IRRIGATION. THERE WAS NO HARM TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8705391 ↗
• MalfunctionMay 3, 2019Material Fragmentation; Material Fragmentation

  THE EVENT INVOLVED AN IRRIGATION SET, LARGE BORE, TUR, UROLOGICAL CONNECTOR 96 INCH, THAT WHEN PUNCTURING THE IV BAG, PIECES OF THE SPIKE WERE SEEN FLOATING IN THE SIGHT CHAMBER. THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577699 ↗
• MalfunctionMay 3, 2019Material Fragmentation; Material Fragmentation

  THE EVENT INVOLVED AN IRRIGATION SET, LARGE BORE, TUR, UROLOGICAL CONNECTOR 96 INCH, THAT WHEN PUNCTURING THE IV BAG, PIECES OF THE SPIKE WERE SEEN FLOATING IN THE SIGHT CHAMBER. THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8577698 ↗
• MalfunctionApr 29, 2019Material Fragmentation; Material Fragmentation

  THE EVENT INVOLVED AN IRRIGATION SET, LARGE BORE, TUR, UROLOGICAL CONNECTOR 96 INCH, THAT WHEN PUNCTURING THE IV BAG, PIECES OF THE SPIKE WERE SEEN FLOATING IN THE SIGHT CHAMBER. THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561689 ↗
• MalfunctionApr 29, 2019Material Fragmentation; Material Fragmentation

  THE EVENT INVOLVED AN IRRIGATION SET, LARGE BORE, TUR, UROLOGICAL CONNECTOR 96 INCH, THAT WHEN PUNCTURING THE IV BAG, B. BRAUN¿S TITAN XL ( 3L NORMAL SALINE FOR IRRIGATION), PIECES OF THE SPIKE WERE SEEN FLOATING IN THE SIGHT CHAMBER. THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561685 ↗
• MalfunctionApr 29, 2019Material Fragmentation; Material Fragmentation

  THE EVENT INVOLVED AN IRRIGATION SET, LARGE BORE, TUR, UROLOGICAL CONNECTOR 96 INCH, THAT WHEN PUNCTURING THE IV BAG, B. BRAUN¿S TITAN XL ( 3L NORMAL SALINE FOR IRRIGATION), PIECES OF THE SPIKE WERE SEEN FLOATING IN THE SIGHT CHAMBER. THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THERE WAS NO ADVERSE EVENT AND NO DELAY IN CRITICAL THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561676 ↗
• MalfunctionApr 3, 2019Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT WHILE USING AN IRRIGATION SET, PIECES OF THE SPIKE BROKE OFF INTO IRRIGATION BAG. THIS OCCURRED DURING BLADDER IRRIGATION ON A PATIENT. THE WAS NO HARM REPORTED. IT WAS FURTHER DESCRIBED THAT THE CUSTOMER SPIKED A 3000L OF NORMAL SALINE AND THAT IS WHEN THE PIECE BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8479888 ↗
• MalfunctionMar 12, 2018Break; Break

  DURING A CYSTOSCOPY-URETEROSCOPY WITH RETROGRADE PYELOGRAM AND LEFT STENT INSERTION/REMOVAL PROCEDURE ON A (B)(6) MALE, THE CUSTOMER ALLEGED THE TIP OF THE IV SPIKE BROKE OFF AND WENT INTO THE PATIENT¿S BLADDER. THE SURGEON RETRIEVED THE BROKEN PIECE OF THE TIP. THE CUSTOMER REPORTED THE PATIENT WAS FINE AND THAT THERE WAS NO INJURY OR OTHERWISE ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7331692 ↗