STATLOCK VUPD1012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741083426), received between Mar 13, 2018 and Feb 24, 2026 — classified as 1 injury, 6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Misconnection

  IT WAS REPORTED CUSTOMER IS HAVING TROUBLE WITH HIS STATLOCK. HE STATES THAT IT HAS NOT STAYED CLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427977 ↗
• MalfunctionFeb 24, 2026Misconnection

  IT WAS REPORTED CUSTOMER IS HAVING TROUBLE WITH HIS STATLOCK. HE STATES THAT IT HAS NOT STAYED CLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24427972 ↗
• MalfunctionFeb 18, 2026Misconnection; Material Deformation

  IT WAS REPORTED THAT THERE IS A PROBLEM WITH THE CLOSING MECHANISM. IT DOES NOT STAY CLOSED, REOPENS AUTOMATICALLY, OR IF IT DOES CLOSE, IT DOES NOT HOLD OVER TIME AND CAN REOPEN AT ANY MOMENT. SEEMS TO APPLY TO ANY SIZE. MOST OF THE TIME PLACED UNDER ULTRASOUND GUIDANCE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384370 ↗
• MalfunctionFeb 17, 2026Misconnection

  IT WAS REPORTED THAT PROBLEM WITH THE CLOSING MECHANISM. IT DOES NOT STAY CLOSED, REOPENS AUTOMATICALLY, OR IF IT DOES CLOSE, IT DOES NOT HOLD OVER TIME AND CAN REOPEN AT ANY MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367790 ↗
• MalfunctionAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT THEIR PRODUCT FELL APART AFTER USE. THE ISSUE WAS THAT THE DEVICE IN THE CENTER OF THE DRESSING CAME UNGLUED (IT APPEARED TO BE GLUE) FROM THE BUTTERFLY DRESSING THAT ADHERED TO THE SKIN. I HAD TO GET A DIFFERENT DRESSING IN THE INTERIM BECAUSE MY DRAIN WAS NO LONGER SUTURED IN PLACE AND I COULDN'T AFFORD TO HAVE IT FALL OUT AND I DIDN'T HAVE ANY BACKUP DRESSINGS AT THE TIME. I BELIEVE IT WAS GLUE OR SOMETHING SIMILAR THAT DETACHED FROM THE DRESSING ITSELF. THE DRESSING WAS CHANGED THE MORNING IT HAPPENED. IT HAD ONLY BEEN IN PLACE 2-3 HOURS AND NEVER GOT WET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22793731 ↗
• MalfunctionJan 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT, "PATIENT RESIDES IN A NURSING HOME UTILIZING STATLOCK WITH HIS NEPHROSTOMY TUBE. PATIENT REQUESTING SAMPLES FROM BARD AS HE ONLY HAS TWO LEFT UNTIL HIS (B)(6) 2024 DOCTOR'S APPOINTMENT. PATIENT'S NURSING HOME ORDERED MEDLINE'S VERSION OF THE STAT LOCK WHICH DID NOT WORK. PATIENT ADVISES HE'S HAD USE MORE OF THE BD'S STABILIZATION DEVICES AS THEY PEELED AWAY WHEN HIS TUBE ACCIDENTLY LEAKED. RESPONSE: INFORMED PATIENT FACILITY ASSISTS CONSUMERS WITH SAMPLE REQUESTS AND ORDERING INFO. PATIENT ADVISED HE'D CONTACTED FACILITY PREVIOUSLY WITH NO SUCCESS. HE STATED HE'D CALLED BARD FOR DRAIN BAG SAMPLES AND RECEIVED THEM. INFORMED PATIENT BARD BECAME A PART OF BD IN 2018; SUGGESTED ORDERING A SMALL QUANTITY FROM AN ONLINE RETAILER UNTIL HIS NEXT APPOINTMENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18434488 ↗
• InjuryMar 13, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT REQUIRED A BILATERAL CHEST TUBE FOR BILATERAL PLEURAL EFFUSIONS. THE CATHETERS THAT WERE USED FOR THORACENTESIS WERE SECURED WITH A STATLOCK. ON THE RIGHT SIDE UNDER THE STATLOCK PATIENT HAD DEVELOPED AN UNSTAGEABLE PRESSURE INJURY. UPON INSPECTION OF THE LEFT SIDE PATIENT WAS NOTED TO BE IN NORMAL CONDITION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 7336805 ↗