STATLOCK PIC0222Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741082962), received between Mar 14, 2019 and Dec 31, 2025 — classified as 1 injury, 17 malfunctions.

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

• MalfunctionDec 31, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE STATLOCK DEVICES HAVE SHARP EDGES ON THE PLASTIC WINGS. THIS IS CREATING HOLES IN THE CENTRAL VENOUS LINE DRESSINGS. NO HARM TO PATIENT AS OF NOW. ROUGH EDGES ARE CAUSING US TO HAVE TO CHANGE DRESSINGS MORE FREQUENTLY. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934503 ↗
• MalfunctionJun 28, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED REMOVAL OF THE STAT LOCK ON PATIENT'S PICC LINE VERY DIFFICULT, DESPITE THE APPLICATION OF 8 ALCOHOL SWABS. SKIN TEAR, 0.4CM LONG ON THE MEDIAL SIDE OF THE ARM WITH STAT LOCK REMOVAL. WOUND CLEANSED AND DRESSED. PICC DRESSING MAY NEED TO BE MORE FREQUENT NOW. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 19637059 ↗
• MalfunctionFeb 29, 2024Misconnection; Misconnection

  IT WAS REPORTED, "USING "STATLOCK PICC PLUS" CATHETER STABILIZATION DEVICE, UNABLE TO FULLY CLOSE OR REMAIN CLOSE PLASTIC WINGS THAT SECURE THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808594 ↗
• MalfunctionFeb 29, 2024Misconnection; Misconnection

  IT WAS REPORTED, "USING "STATLOCK PICC PLUS" CATHETER STABILIZATION DEVICE, UNABLE TO FULLY CLOSE OR REMAIN CLOSE PLASTIC WINGS THAT SECURE THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808404 ↗
• MalfunctionFeb 29, 2024Misconnection; Misconnection

  IT WAS REPORTED, "USING "STATLOCK PICC PLUS" CATHETER STABILIZATION DEVICE, UNABLE TO FULLY CLOSE OR REMAIN CLOSE PLASTIC WINGS THAT SECURE THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808402 ↗
• MalfunctionFeb 29, 2024Misconnection; Misconnection

  IT WAS REPORTED, "USING "STATLOCK PICC PLUS" CATHETER STABILIZATION DEVICE, UNABLE TO FULLY CLOSE OR REMAIN CLOSE PLASTIC WINGS THAT SECURE THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808401 ↗
• MalfunctionFeb 29, 2024Misconnection; Misconnection

  IT WAS REPORTED, "USING "STATLOCK PICC PLUS" CATHETER STABILIZATION DEVICE, UNABLE TO FULLY CLOSE OR REMAIN CLOSE PLASTIC WINGS THAT SECURE THE PICC LINE." NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FIVE DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808399 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18718118 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717402 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE FIFTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712031 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE SIXTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712030 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE FOURTH DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712027 ↗
• MalfunctionFeb 15, 2024Misconnection; Misconnection

  IT WAS REPORTED BY THE CUSTOMER THAT SIDES WILL NOT STAY LOCKED. NO ADVERSE EVENTS REPORTED. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THIS OCCURRED WITH SIX DEVICES. THIS REPORT ADDRESSES THE THIRD DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18712026 ↗
• MalfunctionOct 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT CLIP WAS NOT ADHERING TO ADHESIVE WINGS. IT RESULTED IN PATIENT¿S PICC TO SLIP OUT OF 0.2CM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10617401 ↗
• MalfunctionJun 27, 2019Break

  IT WAS REPORTED THAT DURING A HEALTH FAIR ONE OF THE UNIT CHAMPIONS HAD SHARED THAT THE STATLOCK WING HAD BROKEN OFF ON 3 PIC0222'S THAT WERE USED IN THEIR CUSTOM DRESSING CHANGE KIT. THIS REPORT ADDRESSES THE THIRD OF THREE STATLOCKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741450 ↗
• MalfunctionJun 27, 2019Break

  IT WAS REPORTED THAT DURING A HEALTH FAIR ONE OF THE UNIT CHAMPIONS HAD SHARED THAT THE STATLOCK WING HAD BROKEN OFF ON 3 PIC0222'S THAT WERE USED IN THEIR CUSTOM DRESSING CHANGE KIT. THIS REPORT ADDRESSES THE SECOND OF THREE STATLOCKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741326 ↗
• MalfunctionJun 27, 2019Break

  IT WAS REPORTED THAT DURING A HEALTH FAIR ONE OF THE UNIT CHAMPIONS HAD SHARED THAT THE STATLOCK WING HAD BROKEN OFF ON 3 PIC0222'S THAT WERE USED IN THEIR CUSTOM DRESSING CHANGE KIT. THIS REPORT ADDRESSES THE FIRST OF THREE STATLOCKS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8741324 ↗
• InjuryMar 14, 2019Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT REACTED VIGOROUSLY TO THE PAD/ADHESIVE PART OF A STATLOCK DEVICE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8421215 ↗