StatLock Urological STATURO25Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741215902), received between Oct 20, 2022 and Oct 20, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Close” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUSTOMER HAD SOME FEEDBACK FROM THE SOUTH REGARDING THE NEW UNIVERSAL STATLOCKS. THEY NOTICED A SIGNIFICANT NUMBER OF PATIENTS WHERE THE CATHETER WAS COMING OUT OF THE STATLOCK AND THEN IT WAS NEXT TO IMPOSSIBLE TO GET THE CATHETER BACK INTO THE STATLOCK ONCE IT WAS ALREADY ON THE PATIENT, SO THEY WERE HAVING TO REMOVE AND APPLY A NEW ONE FREQUENTLY. THEY TESTED OUT THE HOLDING POWER OF THIS NEW STATLOCK VS THE OLD ONE AND THERE WAS A BIG DIFFERENCE. SMALL MOVEMENTS POP THE FOLEY OUT OF THE UNIVERSAL STATLOCK, WHERE AS THE OLD ONES REALLY HOLD REGARDLESS OF MOVEMENT. PER FOLLOW UP VIA PHONE ON 18OCT2022, IT WAS REPORTED THAT THE UNIVERSAL STAT LOCK WAS VERY DIFFICULT TO CLOSE AROUND THE INDWELLING URETHRAL CATHETER AND IT ALSO OPENED VERY EASILY EVEN WITH THE LITTLE MOVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638145 ↗