STATLOCK VUPD68Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741083488), received between Apr 29, 2025 and Mar 31, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Misconnection” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Misconnection

  IT WAS REPORTED BY CUSTOMER THAT THE SLIT APPEARS SMALLER (NARROWER) THAN USUAL. THE DRAIN DOESN'T STAY IN PLACE AND THEREFORE SLIPS OUT. NO PATIENT HARM. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744001 ↗
• MalfunctionApr 30, 2025Misconnection; Misconnection

  IT WAS REPORTED "BY REMOVING THE STAT LOCK IT IS OPEN AND THE PLURAL DRAIN IS FREE. WE CHANGE THE STAT LOCK, CLOSE IT AND BEFORE CLOSING THE DRESSING, ABOUT 1 MINUTE AFTER CLOSING THE SYSTEM THE STAT LOCK OPENS UNDER THE EYES OF THE NURSE WHO NOTIFIES THE HEMATOLOGIST AND THE PULMONOLOGIST. ON THE RADIO ID WE SEE THAT THE STAT LOCK HAS BEEN OPEN SINCE THE BEGINNING AND THAT THE DRAIN IS USED EVERY DAY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940322 ↗
• MalfunctionApr 30, 2025Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER "BY REMOVING THE STAT LOCK IT IS OPEN, AND THE PLURAL DRAIN IS FREE. WE CHANGE THE STAT LOCK, CLOSE IT AND BEFORE CLOSING THE DRESSING, ABOUT 1 MINUTE AFTER CLOSING THE SYSTEM THE STAT LOCK OPENS UNDER THE EYES OF THE NURSE WHO NOTIFIES THE HEMATOLOGIST AND THE PULMONOLOGIST. ON THE RADIO ID WE SEE THAT THE STAT LOCK HAS BEEN OPEN SINCE THE BEGINNING AND THAT THE DRAIN IS USED EVERY DAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21938705 ↗
• MalfunctionApr 29, 2025Misconnection; Misconnection

  IT WAS REPORTED BY REMOVING THE STAT LOCK IT IS OPEN AND THE PLURAL DRAIN IS FREE. WE CHANGE THE STAT LOCK, CLOSE IT AND BEFORE CLOSING THE DRESSING, ABOUT 1 MINUTE AFTER CLOSING THE SYSTEM THE STAT LOCK OPENS UNDER THE EYES OF THE NURSE WHO NOTIFIES THE HEMATOLOGIST AND THE PULMONOLOGIST. ON THE RADIO ID WE SEE THAT THE STAT LOCK HAS BEEN OPEN SINCE THE BEGINNING AND THAT THE DRAIN IS USED EVERY DAY. NO PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21927408 ↗