STATLOCK VUPD1214Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741083440), received between Jan 3, 2020 and Nov 3, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Misconnection; Misconnection

  IT WAS REPORTED STAT LOCK CATHETERS AND THE CLAPS ARE NOT WORKING. THE CUSTOMER HAS TO GO THROUGH 2-3 OF BEFORE SHE CAN GET ONE TO WORK. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES ALL EIGHT DEVICES. 10/28/2025: IT WAS FOUND DURING AN INVESTIGATION THERE WAS DIFFICULTY KEEPING THE LATCHES CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23450567 ↗
• MalfunctionJun 2, 2025Misconnection; Misconnection

  IT WAS REPORTED THAT THEY WENT TO PUT IT ON TO PUT THE TOP DOWN IT KEPT POPPING OFF. HUSBAND TRIED TO ATTACH AND IT WOULD NOT LOCK, TRIED A SECOND ONE WHICH LOCKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126498 ↗
• MalfunctionApr 8, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED BY CUSTOMER THAT STATLOCK DRESSING LIFTED COMPLETELY ON LEFT SIDE DUE TO PURULENT DRAINAGE. STATLOCK REQUIRES CHANGE, SAME REMOVED. DRAIN CATHETER HELD IN SITU WITH GAUZE AND MANUAL PRESSURE AS MIGRATING OUT. CAVILON APPLIED. NEW STATLOCK PLACED AND LARGE CENTRAL LINE TRANSPARENT TEGADERM TO REINFORCE. STOPCOCK WITH IV CAP ADDED TO MAINTAIN A CLOSED SYSTEM TID FOR NS 10ML FLUSHES. PATIENT'S 3RD CT GUIDED DRAIN INSERTION WITHIN 1 MONTH. THE 2 PREVIOUS MIGRATED OUT WHEN SECURED WITH STATLOCK. REQUESTED SECURACATH TO BE PLACE AND PREVENT LINE MIGRATION. PATIENT WAS TRANSFERRED TO SMALL RURAL SITE. THERE WAS NO PATIENT INJURY REPORTED. IT WAS STATED THIS OCCURRED WITH THREE DEVICES ON THE SAME PATIENT. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063050 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE SECOND OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547715 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE NINTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547659 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE EIGHTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547654 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE FIRST OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547638 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE FOURTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547587 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE TENTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547574 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO CHANGE THEM MORE OFTEN THAN USUAL. SO FAR IN THE BOX USERS HAVE FOUND 4 OR 5 THAT IS DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE SIXTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547564 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE FIFTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547559 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE THIRD OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547554 ↗
• MalfunctionJan 3, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT STATLOCK (VUPD1214) ARE NOT STICKING PROPERLY, AND NEED TO BE CHANGED MORE OFTEN THAN USUAL. IT WAS STATED THAT SO FAR, IN THE BOX USERS HAVE FOUND 4 OR 5 THAT ARE DEFECTIVE. ON 1/3/2020: QUANTITY WAS UPDATED TO 10 NOT STICKING PROPERLY. THIS REPORT ADDRESSES THE SEVENTH OF TEN DEVICES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9547553 ↗