STATLOCK PIC0220Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00801741082948), received between Jun 14, 2016 and Jan 7, 2026 — classified as 4 injuries, 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (18 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 25 most recent of 47 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER PLACING STATLOCK, PATIENT IMMEDIATELY SUFFERED ALLERGIC REACTION. NO PATIENT INJURY WAS REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction

  MAUDE report 23995662 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT, SHE IS CURRENTLY USING A STATLOCK AND HAS DEVELOPED A RED RASH THAT HAS LITTLE BLISTER THAT LEAKS YELLOW FLUID AND IS ITCHY UNDER THE AREA OF THE STATLOCK. SHE STATES SHE HAS A KNOWN ALLERGY TO ADHESIVES.

  Patient problems: Blister; Itching Sensation; Local Reaction

  MAUDE report 22383129 ↗
• MalfunctionJan 13, 2025Misassembled; Misconnection; Misassembled; Misconnection

  IT WAS REPORTED INSIDE STATLOCK ARE 2 LITTLE BLUE TABS (SLIDING POST RETAINERS) THAT HAVE POSTS THAT INSERT INTO "WINGS" OF THE PICC INE. THE RIGHT BLUE TAB IS LOCKED AND IMMOBILE WITHIN THE STATLOCK. AS A RESULT, NURSE HAD DIFFICULTY PLACING PICC "WINGS" AND PULLED LINE 4CM. WE PUT ANOTHER ON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21143234 ↗
• MalfunctionJun 19, 2024Loss of or Failure to Bond; Difficult to Remove; Loss of or Failure to Bond; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER THE STATLOCK IS ADHERING TO THE 3M BORDERED DRESSING. DRESSING TOOK LONGER TO REMOVE, ADDING 20 MINUTES TO THE VISIT AND MULTIPLE GLOVE CHANGES. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566841 ↗
• MalfunctionJun 7, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING CHEMOTHERAPY, CATHETER STABILIZATION DEVICE REQUIRED REPLACEMENT DUE TO IMPROPER GUMMING FOR PROPER ADHESION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19481734 ↗
• MalfunctionJun 5, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT DURING CHEMOTHERAPY, CATHETER STABILIZATION DEVICE REQUIRED REPLACEMENT DUE TO IMPROPER GUMMING FOR PROPER ADHESION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469172 ↗
• MalfunctionMay 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT STATLOCK SLIDING POST WAS NOT MOVING TO ENCLOSE THE PICC LINE WING DURING DRESSING CHANGE. NURSE AT FACILITY USED OTHER FRESH STATLOCK AND RESOLVE THE ISSUE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19374902 ↗
• MalfunctionApr 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THE PLASTIC PART OF STATLOCK DEVICE SEPARATED FROM THE DRESSING SECTION BELOW (PICC + LOCKING DEVICE LEFT FREE TO HANG). DEVICE HAD TO BE REPLACED. NO INJURY/HARM FROM THIS EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19195683 ↗
• MalfunctionFeb 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT STATLOCK FROM DDI WAS USED ON PATIENT WAS FOUND TO BE DETACHED FROM THE TAPE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18809630 ↗
• MalfunctionSep 11, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLEAR PLASTIC DEVICE CAME APART, WHERE THE DEVICE MET THE PAPER BACKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10524779 ↗
• MalfunctionSep 10, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  "0147 PT'S MOTHER CALLED RN STATED PT'S PICC DRESSING WAS NO LONGER INTACT. RN WENT TO BEDSIDE TO ASSESS PICC SITE, FOUND BOTTOM OF DRESSING TO BE LIFTED. MOTHER HELD PT'S ARM TO PREVENT MOVEMENT OF PICC LINE. RN NOTIFIED MOTHER WOULD BE BACK SHORTLY TO PERFORM DRESSING CHANGE." "0155-0225 RN WENT BACK TO BEDSIDE WITH RN, RN, AND RN TO PERFORM PICC DRESSING CHANGE. UPON CLOSER EXAMINATION, FOUND PICC PLUS STATLOCK HAD MALFUNCTIONED (PLASTIC WINGS WHILE STILL ATTACHED TO PICC HAD LIFTED UP OFF OF STATLOCK PAD). DRESSING AND STATLOCK DEVICE REMOVED, NOTED THAT APPROXIMATELY 1CM OF CATHETER WAS EXPOSED. RN ASKED MOTHER IF MORE OF THE CATHETER APPEARED TO BE EXPOSED SINCE LAST DRESSING CHANGE. MOM STATED THAT IT LOOKED ABOUT THE SAME, POSSIBLY A LITTLE LONGER. PICC DRESSING CHANGE PERFORMED INCLUDING NEW STATLOCK DEVICE (PICC PLUS PEDIATRIC). RN NOTIFIED PT'S MOTHER THAT MEDICAL TEAM WILL BE MADE AWARE OF NEED FOR DRESSING CHANGE. ALSO INFORMED MOM OF POSSIBLE NEED FOR CHEST X-RAY TO CONFIRM CORRECT PLACEMENT OF PICC. MOM VERBALIZED UNDERSTANDING." ADDITIONAL INFO. RECEIVED 08/19/2020: "WAS THERE PATIENT HARM REPORTED?: 'YES, SEVERITY UNKNOWN". "WHAT THEY¿RE BEING TREATED FOR: 'TRANSPL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518255 ↗
• MalfunctionSep 10, 2020Loss of or Failure to Bond; Disconnection; Loss of or Failure to Bond; Disconnection

  IT WAS REPORTED THAT COMPLAINANT RECEIVED A CALL DIRECTLY FROM ATTENDANT OF PATIENT WHERE THEY MENTIONED THAT STATLOCK LOOSES ITS STICKNESS WITHIN 8-10 DAYS. IT WAS STATED ACCORDING TO THEM AND BASED ON THEIR PREVIOUS EXPERIENCE STATLOCK LAST ON SKIN FOR SIX MONTHS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518253 ↗
• MalfunctionSep 10, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  "0147 - PT'S MOTHER CALLED RN STATED PT'S PICC DRESSING WAS NO LONGER INTACT. RN WENT TO BEDSIDE TO ASSESS PICC SITE, FOUND BOTTOM OF DRESSING TO BE LIFTED. MOTHER HELD PT'S ARM TO PREVENT MOVEMENT OF PICC LINE. RN NOTIFIED MOTHER WOULD BE BACK SHORTLY TO PERFORM DRESSING CHANGE." "(B)(6) - RN WENT BACK TO BEDSIDE WITH RN, RN, AND RN TO PERFORM PICC DRESSING CHANGE. UPON CLOSER EXAMINATION, FOUND PICC PLUS STATLOCK HAD MALFUNCTIONED (PLASTIC WINGS WHILE STILL ATTACHED TO PICC HAD LIFTED UP OFF OF STATLOCK PAD). DRESSING AND STATLOCK DEVICE REMOVED, NOTED THAT APPROXIMATELY 1CM OF CATHETER WAS EXPOSED. RN ASKED MOTHER IF MORE OF THE CATHETER APPEARED TO BE EXPOSED SINCE LAST DRESSING CHANGE. MOM STATED THAT IT LOOKED ABOUT THE SAME, POSSIBLY A LITTLE LONGER. PICC DRESSING CHANGE PERFORMED INCLUDING NEW STATLOCK DEVICE (PICC PLUS PEDIATRIC). RN NOTIFIED PT'S MOTHER THAT MEDICAL TEAM WILL BE MADE AWARE OF NEED FOR DRESSING CHANGE. ALSO INFORMED MOM OF POSSIBLE NEED FOR CHEST X-RAY TO CONFIRM CORRECT PLACEMENT OF PICC. MOM VERBALIZED UNDERSTANDING." ADDITIONAL INFO. RECEIVED 08/19/2020: "WAS THERE PATIENT HARM REPORTED?: 'YES, SEVERITY UNKNOWN." "WHAT THEY¿RE BEING TREATED FOR: 'TRANSP

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10518251 ↗
• MalfunctionAug 21, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NURSE NOTED THAT THE PLASTIC LOCKING APPARATUS APPEARED TO BE SEPARATING FROM THE ADHESIVE STRIP WHEN INSPECTING THE DRESSING, A SECOND DEVICE WAS REQUIRED. CUSTOMER REPORTED PATIENT INJURY AND MEDICAL INTERVENTION WAS REQUIRED. IT WAS FURTHER REPORTED THAT THE DEVICE MIGRATED OUT OF POSITION AND ADDITIONAL DIAGNOSTIC TESTING WAS REQUIRED TO ENSURE THE CATHETER COULD STILL BE USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10436195 ↗
• MalfunctionAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PLASTIC CLIP COMES AWAY FROM THE STICKY ADHESIVE PAD. HAPPENED WITH TOTAL TO DATE X4. OF THOSE, 3 WERE USED ON PATIENTS AND FELL APART WITHIN 3 DAYS. 1 SAMPLE BEING RETURNED STRAIGHT FROM PACKET NOT USED ON PATIENT, WHERE GENTLE PULLING CAUSED THE PLASTIC CLIP TO SEPARATE EASILY. THIS REPORT ADDRESSES THE FOURTH DEVICE, THIS DEVICE WAS NOT USED ON A PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372806 ↗
• MalfunctionAug 6, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT PLASTIC CLIP COMES AWAY FROM THE STICKY ADHESIVE PAD. HAPPENED WITH TOTAL TO DATE X4. OF THOSE, 3 WERE USED ON PATIENTS AND FELL APART WITHIN 3 DAYS. 1 SAMPLE BEING RETURNED STRAIGHT FROM PACKET NOT USED ON PATIENT, WHERE GENTLE PULLING CAUSED THE PLASTIC CLIP TO SEPARATE EASILY. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372798 ↗
• MalfunctionAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PLASTIC CLIP COMES AWAY FROM THE STICKY ADHESIVE PAD. HAPPENED WITH TOTAL TO DATE X4. OF THOSE, 3 WERE USED ON PATIENTS AND FELL APART WITHIN 3 DAYS. 1 SAMPLE BEING RETURNED STRAIGHT FROM PACKET NOT USED ON PATIENT, WHERE GENTLE PULLING CAUSED THE PLASTIC CLIP TO SEPARATE EASILY. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372783 ↗
• MalfunctionAug 6, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PLASTIC CLIP COMES AWAY FROM THE STICKY ADHESIVE PAD. HAPPENED WITH TOTAL TO DATE X4. OF THOSE, 3 WERE USED ON PATIENTS AND FELL APART WITHIN 3 DAYS. 1 SAMPLE BEING RETURNED STRAIGHT FROM PACKET NOT USED ON PATIENT, WHERE GENTLE PULLING CAUSED THE PLASTIC CLIP TO SEPARATE EASILY. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10372768 ↗
• MalfunctionJul 23, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314394 ↗
• MalfunctionJul 23, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE TENTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314390 ↗
• MalfunctionJul 23, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314380 ↗
• MalfunctionJul 23, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314374 ↗
• MalfunctionJul 23, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE EIGHTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314373 ↗
• MalfunctionJul 23, 2020Disconnection; Detachment of Device or Device Component; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314369 ↗
• MalfunctionJul 23, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE CLIP OF THE STATLOCK HAS COMPLETELY DETACHED FROM THE TICOT PAD WHEN USING ON A PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TEN DEVICES. THIS REPORT ADDRESSES THE NINTH DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10314363 ↗