STATLOCK DI0120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741081637), received between Aug 11, 2016 and Jan 3, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PATIENT NOTED BLOOD AND ASKED THAT THE DEVICE BE REMOVED. THE DRESSING WAS SATURATED WITH DRIED SANGUINEOUS. A TINY OPENING THROUGH THE ARTERIAL LINE WAS FOUND DUE TO THE STAT LOCK PLACEMENT. THE STAT LOCK WAS UNABLE TO BE REMOVED AS THE EDGE WAS CUTTING THROUGH THE CATHETER. PATIENT UNABLE TO START DIALYSIS, DELAYED CARE. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21068762 ↗
• MalfunctionSep 7, 2017Device Operates Differently Than Expected

  IT WAS REPORTED BY THE CUSTOMER THAT ABOUT 2 WEEKS AGO USER WAS APPLYING A STATLOCK TO A PATIENT AND BEFORE USER HAD COMPLETELY REMOVED THE BACKING FROM ONE SIDE OF THE DEVICE THE LOCKING MECHANISM POPPED OPEN. THIS WAS REMOVED FROM THE PATIENT AND A DIFFERENT DEVICE WAS APPLIED. IT WAS STATED THAT THIS FAILURE DID NOT HAVE PATIENT MOVEMENT AS A FACTOR. THE TYPE OF CATHETER THE STATLOCK IS USED TO SECURE IS THE SAME CATHETER THE MAJORITY OF THE PATIENTS HAVE SINCE THEIR CATHETERS ARE INSERTED IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT AT REGINA GENERAL HOSPITAL, THE HEMOSTAR IS THE CATHETER USED THERE. THERE WAS NO HARM TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6848861 ↗
• MalfunctionDec 15, 2016Application Program Problem

  IT WAS REPORTED THAT WHEN MAKING STATLOCK CHANGES, IN THE FIRST CHANGE, THE WHITE CLIP DIDN'T OPEN AND REQUIRED FORCE WITH SCISSORS AND FORCEPS TO OPEN IT JEOPARDIZING THE INTEGRITY OF THE PATIENT AND DAMAGING THE CATHETER. IN THE OTHER CHANGES, THE CLIP DIDN'T CLOSE PROPERLY. ON 11/22/2016 - DURING INVESTIGATION, IT WAS DISCOVERED THAT THE STATLOCK DOOR OPENED SPONTANEOUS WHEN TOUCHED BUT WITHOUT ENGAGING THE RELEASE BUTTON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6175926 ↗
• MalfunctionDec 6, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE STATLOCK WAS POPPING OPEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6149409 ↗
• MalfunctionNov 4, 2016Device Operates Differently Than Expected

  NURSE REPORTED THAT THE USER CHANGED THE STATLOCK AND THAT IT CLIPPED ON CORRECTLY. REPORT CONTINUED STATING THAT BY THE END OF DIALYSIS TREATMENT, THE STATLOCK HAD ALLEGEDLY POPPED OPEN WOULD NOT RE-CLIP. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6080842 ↗
• MalfunctionSep 15, 2016Difficult to Open or Close

  IT WAS REPORTED THAT THE STATLOCK ALLEGEDLY POPPED OPEN AND THE PATIENT COULD NOT CLOSE IT. THIS REPORT ADDRESSES THE FIRST STATLOCK THAT THE PATIENT HAD. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5954583 ↗
• MalfunctionSep 15, 2016Difficult to Open or Close

  IT WAS REPORTED THAT THE STATLOCK ALLEGEDLY POPPED OPEN AND THE PATIENT COULD NOT CLOSE IT. THIS REPORT ADDRESSES THE SECOND STATLOCK THAT THE PATIENT HAD. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5954565 ↗
• MalfunctionAug 19, 2016Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER THE NURSE PLACED THE STATLOCK TO THE HEMODIALYSIS CATHETER ON THE PATIENT, IT ALLEGEDLY POPPED OPEN MINUTES LATER. THE NURSE PLACED A NEW STATLOCK AND IT WORKED OK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5889693 ↗
• MalfunctionAug 11, 2016Disconnection

  IT WAS REPORTED THAT AFTER THE NURSE PLACED THE STATLOCK TO THE HEMODIALYSIS CATHETER AND ON THE PATIENT, IT ALLEGEDLY POPPED OPEN MINUTES LATER. THE NURSE PLACED A NEW STATLOCK AND IT WORKED CORRECTLY. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5870109 ↗