Catheter Stabilization Device FOL0105Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741076145), received between Mar 26, 2018 and Sep 12, 2025 — classified as 1 injury, 23 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT'S THERMISTOR FOLEY CATHETER INSERTED ON (B)(6) 2025. ON (B)(6) 2025, PT'S BLADDER TEMPERATURE READING WAS BETWEEN 5-20 DEGREES CELSIUS, BUT TEMPORAL WAS 36.3 - 36.5 AT THE SAME TIME (B)(4). FOLEY REMOVED AND REPLACED WITH A NEW THERMISTOR FOLEY CATHETER PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 04SEP2025, IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER MALFUNCTIONED. THEY WANTED TO CHECK WHETHER THE CATHETER WAS PROPERLY SECURED USING A STATLOCK DEVICE DURING ITS DWELL TIME (B)(6). THE REASON WAS THAT THE 3-WAY STATLOCK INCLUDED IN THE SURESTEP TRAY HAS A RECOMMENDED WEAR TIME OF 7 DAYS. IT¿S IMPORTANT TO NOTE THAT NEITHER CDC NOR PETER LOUGHEED HAS ANY ORDER HISTORY FOR THE 3-WAY FOLEY STATLOCK (SKU FOL0105). IF A STATLOCK WASN¿T USED¿OR IF A LEG STRAP WAS USED INSTEAD¿THERE¿S AN INCREASED RISK OF CATHETER PISTON-ING, MIGRATION, BENDING, AND EXCESSIVE TENSION. THESE FACTORS CAN COMPROMISE THE LONGEVITY AND PERFORMANCE OF THE CATHETER AND MAY CONTRIBUTE TO EARLY FAILURE. ADDITIONALLY, IMPROPER SECUREMENT INCREASES THE RISK OF CATHETER-ASSOCIATED URINARY TRACT INFECTIONS (CAUTIS). MANUFACTURER COMMITTED TO ENSURING OUR PRODUCTS MEE

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 23037815 ↗
• MalfunctionJul 10, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH ADHESIVE ON THE STATLOCKS TO MAKE THEM STICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709709 ↗
• MalfunctionOct 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK ADHESIVE WAS NOT STICKY ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894311 ↗
• MalfunctionSep 13, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY CATHETER STATLOCK THAT HOLDED THE CATHETER IN PLACE WAS NOT FUNCTIONING PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17737508 ↗
• MalfunctionDec 29, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT SOME STATLOCKS WOULD BREAK WHEN THEY TRIED TO CLIP IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16068637 ↗
• MalfunctionSep 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE GLUE THAT HELD TWO PIECES TOGETHER IN STATLOCK DID NOT STICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361434 ↗
• MalfunctionJul 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK ADHESIVE KEPT COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916012 ↗
• MalfunctionMay 4, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE PLASTIC HOLDER PORTION WAS TOO LARGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11769234 ↗
• MalfunctionDec 29, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WAS AN UNKNOWN EVENT. PER FOLLOW UP VIA PHONE ON (B)(6) 2020, IT WAS STATED THAT THE CLIP OF THE STATLOCK WAS POPPING OFF DURING USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087571 ↗
• MalfunctionNov 3, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STATLOCK WAS BROKEN AND THE PLASTIC PIECE OF THE BUTTON WAS UNGLUED FROM THE STICKY PAD. PER FOLLOW UP VIA PHONE ON (B)(6) 2020, PLASTIC PIECE DISCONNECTED FROM THE ADHESIVE PAD AFTER 2 DAYS OF USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778835 ↗
• MalfunctionOct 26, 2020Disconnection; Disconnection

  IT WAS REPORTED THAT THE 3 - WAY STATLOCK CAME APART WHEN THE PATIENT TRIED TO USE THEM AND ALSO STATED THAT 3 OUT OF 5 STATLOCKS HAD THE SAME ISSUE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10734327 ↗
• MalfunctionSep 8, 2020Loss of or Failure to Bond; Material Separation; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE CENTER BAND THAT STUCK TO LEG, KEPT POPPING OFF. THE BUTTONS ALSO KEPT POPPING OFF IN THE CENTER WHERE IT STUCK TO THE LEG, THE BUTTON THAT HOLDS THE FOLEY POPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10501057 ↗
• MalfunctionSep 4, 2020Disconnection; Material Separation; Disconnection

  IT WAS REPORTED THAT THE 3 - WAY STATLOCK CAME APART WHEN THE PATIENT TRIED TO USE THEM AND ALSO STATED THAT 3 OUT OF 5 STATLOCKS HAD THE SAME ISSUE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10497130 ↗
• MalfunctionSep 1, 2020Disconnection; Detachment of Device or Device Component; Disconnection

  IT WAS REPORTED THAT THE CENTER BAND THAT STUCK TO LEG, KEPT POPPING OFF. THE BUTTONS ALSO KEPT POPPING OFF IN THE CENTER WHERE IT STUCK TO THE LEG, THE BUTTON THAT HOLD THE FOLEY POPPED OFF.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10480031 ↗
• MalfunctionJun 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK WOULD NOT STICK WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214951 ↗
• MalfunctionJun 30, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK WOULD NOT STICK PROPERLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10214939 ↗
• MalfunctionMay 1, 2020Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ANCHOR PADS RIPPED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10017766 ↗
• MalfunctionApr 8, 2020Disconnection

  IT WAS REPORTED THAT THE STATLOCK DISCONNECTED FROM THE ADHESIVE PAD.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9934235 ↗
• MalfunctionJan 3, 2020Disconnection; Disconnection; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PLASTIC CLAMP CAME OFF THE ADHESIVE PAD AFTER A COUPLE HOURS OF USE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9545110 ↗
• MalfunctionAug 30, 2019Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE STATLOCK DEVICE WAS DIFFICULT TO REMOVE AT TIMES BECAUSE THE ADHESIVE WAS TOO STICKY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8951134 ↗
• MalfunctionJun 18, 2019Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PRODUCTS WERE NOT STICKING WELL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8708113 ↗
• MalfunctionMar 18, 2019Loss of or Failure to Bond; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE STATLOCK HAD WEAK ADHESIVE AND CONTINUOUSLY FELL OFF. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8429503 ↗
• MalfunctionNov 5, 2018Loss of or Failure to Bond; Loss of or Failure to Bond; Malposition of Device; Device Fell

  IT WAS REPORTED THAT THE STATLOCK WOULD NOT STAY IN PLACE AND WAS FALLING OFF THE PATIENT'S LEG.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8039062 ↗
• MalfunctionMar 26, 2018Fitting Problem

  IT WAS REPORTED THAT THE 24FR SILICONE CATHETER USED BY THE PATIENT, WOULD NOT FIT PROPERLY IN THE STATLOCK DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7370780 ↗