Catheter Stabilization Device FOL0101Recalls & reported problems

Summary

The FDA's MAUDE database contains 240 adverse event reports that list this exact device (DI 00801741076091), received between May 31, 2017 and Feb 7, 2024 — classified as 7 injuries, 233 malfunctions.

The most frequently reported specific device problem is “Disconnection” (144 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 240 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2024Device Handling Problem; Device Handling Problem

  CRITICAL CARE NURSES REPORTED THAT URINARY MEATUS INJURY WAS A DEVICE USE RELATED COMPLICATION THAT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION - INTERVENTION NOT SPECIFIED IN RELATION TO PRODUCT FOL0100- SL FOLEY SWIVEL SILICONE FOLYADLTW/PERSHFORLTXCATHSL FOLEY SWIVEL SILICONESTATLOCK. PER ADDITIONAL INFORMATION FROM UCC RECEIVED ON 07FEB2024, UPON RECEIPT OF THE FINAL DATASET FOR THE STATLOCK FOLEY STABILIZATION DEVICE. PREVIOUSLY HAD FOL0100 AS THE PRODUCT CODE. THIS SHOULD HAVE BEEN FOL0101 AND HAS BEEN UPDATED IN THE FORMS ATTACHED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18658104 ↗
• MalfunctionSep 6, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT 2 DIFFERENT STABILIZATION DEVICES FOR THEIR FOLEY CATHETER HAD POPPED OFF AND DID NOT STAY. THE CUSTOMER STATED THAT AFTER THE SECOND ONE WOULD NOT STAY, THEY WENT TO THE EMERGENCY TO GET ONE PLACED FOR THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17690286 ↗
• MalfunctionAug 14, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT WITH 3 (THREE) SEPARATE FOLEY STATLOCK STABILIZATION DEVICES, THE CUSTOMER BELIEVED THE STABILIZATION DEVICE WAS CRIMPING THE CATHETER TUBING AND CREATING A PROBLEM FOR THE URINE FLOW. IT WAS NOTED THAT THERE WAS NO SEDIMENT IN THE TUBE AND NO ISSUE WITH THE CATHETER. THERE WAS A SNAP TO KEEP THE DEVICE IN PLACE, THUS THE CUSTOMER COULD NOT PUT THE DEVICE ON INCORRECTLY. MORE OFTEN THAN NOT, THE BUTTERFLY STABILIZATION DEVICE WAS IN PLACE AND SNAPPED, BUT NO URINE WOULD GO THROUGH THE FOLEY CATHETER TUBING INTO THE FOLEY BAG. IT WAS NOTED THAT THIS ISSUE WAS NOT DUE TO LACK OF GRAVITY. AS SOON AS THE FOLEY CATHETER TUBING WAS UNSNAPPED, THE BAG WOULD BE FILLED. THE CUSTOMER BELIEVED THE FOLEY WAS CUTTING OFF THE URINE FLOW FROM THE CATHETER. THERE WOULD BE 8-9 HOURS WITH NO URINE FLOW, BUT ONCE THE STABILIZATION DEVICE WAS REPLACED WITH TAPE OR JUST FREE HANGING, THE URINE FLOW WOULD BE INSTANT. TUBES CLEAR, PROPERLY INSTALLED. THE CUSTOMER FEARED PEOPLE COULD DIE FROM RUPTURED BLADDERS, URINARY TRACT INFECTIONS (UTIS), OR KIDNEY INFECTIONS. THE CUSTOMER ALSO STATED THIS WAS A CONTINUOUS ISSUE, NOT JUST SINGLE TIME. AT ONE POINT IN THE HOSPITAL, THERE WAS NO UR

  Patient problems: Urinary Retention

  MAUDE report 17540869 ↗
• MalfunctionJul 26, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING TROUBLE WITH THE SAFETY LOCKS POPPING OPEN, DID NOT SEEM TO ENGAGE VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396809 ↗
• MalfunctionJul 19, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE STATLOCK WAS NOT FITTING OVER CATHETER TUBING, WOULD NOT CLOSE OVER CATHETER TUBING. (FOLO101-LOT#JUHN8645) AND (FOLO102-LOT#JUGP0311)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349455 ↗
• MalfunctionJun 23, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT FOLEY STATLOCKS DID NOT CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190217 ↗
• MalfunctionMay 5, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE FOLEY STATLOCK WAS DEFECTIVE BECAUSE IT WAS TO TIGHT OF A FIT AND ,THE TIP WOULD NOT FIT ON MACHINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875322 ↗
• MalfunctionApr 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE ITEM WAS DEFECTIVE THE FOLEY STATLOCKS WERE NOT STICKING, WHEN BEING USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16712447 ↗
• MalfunctionMar 8, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE FOLEY STATLOCK WAS NOT WORKING, AND IT WAS TOO SMALL, SO THE TUBE WAS NOT FITTING. THE NURSE WAS NOT ABLE TO MAKE IT WORK EITHER THEY USED THREE OUT OF THE BOX OF TEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503874 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY STATLOCK DID NOT HOLD THE TUBING AND THE PATIENT ENDED UP WITH LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272739 ↗
• MalfunctionNov 18, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY STAT LOCKS KEPT COMING UNDONE. THE USER ASKED IF THE MANUFACTURE HAD CHANGED ANYTHING, INFORMED NO. THE PATIENT THOUGHT THE CAREGIVER MAYBE PUTTING ON WRONG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827621 ↗
• MalfunctionNov 18, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE STATLOCK SNAPS WERE NOT STAYING SNAPPED AS WELL AS THEY HAD BEFORE, AND AT LEAST 6 TO 7 WERE AFFECTED. USUALLY THEY LAST BETWEEN ONE AND THREE WEEKS, BUT FOR THE PAST MONTH OR SO, CUSTOMERS HAVE HAD TO CHANGE THEM EVERY 2-3 DAYS AND HAD TO CHANGE THEM TWICE YESTERDAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827410 ↗
• MalfunctionOct 27, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK WAS UNCLIPPING BY ITSELF AND NOT STICKING VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679677 ↗
• MalfunctionOct 27, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE STATLOCK WAS UNCLIPPING BY ITSELF AND NOT STICKING VERY WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15679583 ↗
• MalfunctionSep 28, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE STATLOCK WOULD NOT CLOSE AND POPPED OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15496028 ↗
• MalfunctionAug 17, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER HAD PROBLEMS WITH FOLEY STATLOCKS NOT STAYING CLOSED AND THE CATHETER TUGGING. THE REPRESENTATIVE DISCUSSED WITH CUSTOMER IF THEY WERE USING THE CORRECT STATLOCK FOR THEIR FOLEY. CUSTOMER ONLY KNEW IT WAS A 2-WAY 18FR, BUT DID NOT KNOW THE SUBSTRATE OR TYPE. IT WAS STATED THAT THE STATLOCK ONLY STAYED CLOSED FOR A FEW MINUTES AND THEN POPPED OPEN. THE CUSTOMER HAD ALSO TRIED THE LEG STRAP OPTION BUT THAT CAUSED URETHRAL AND MEATAL TRAUMA, STATED THEY DID NOT REPORT THE LEG STRAP ISSUE. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15240838 ↗
• MalfunctionJul 12, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THERE INTEGRATED PRACTICE UNIT HAD REACHED PATIENT THIS MORNING WITH ISSUES ON SOME FOLEY STATLOCKS THAT WERE NOT WANTING TO OR STATING SNAPPED IN PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986045 ↗
• MalfunctionJun 28, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY STATLOCK KEPT POPPING OPEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843281 ↗
• MalfunctionMay 2, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE STATLOCK WOULD NOT STICK AT PATIENT SKIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257590 ↗
• MalfunctionNov 11, 2021Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE FOLEY STATLOCK DID NOT FIT. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12794956 ↗
• MalfunctionOct 13, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY STATLOCK WOULD NOT STAY LOCKED. PATIENT HAD BEEN USING FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624728 ↗
• MalfunctionSep 2, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT MULTIPLE STATLOCKS POPPED OPEN AND THE CATHETER DROPPED SEVERAL TIMES IN THE NIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12415938 ↗
• MalfunctionSep 1, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE FOLEY STATLOCK POP UP EVERY TIME AND ALSO STATED IT SEEMS TO BE SMALL FOR CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406507 ↗
• MalfunctionAug 31, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT THE STATLOCK DID NOT HOLD THE HOSE, AND IT RANDOMLY DISCONNECTED. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE FROM THE CUSTOMER ON (B)(6) 2021, IT WAS STATED THAT THE CUSTOMER WAS TRYING TO PUT A CLIP AROUND BOTH THE CATHETER AND THE ACCESS PORT WHICH MADE IT DIFFICULT TO COORDINATE, AND THEN IT WOULD DISCONNECT AND NOT HOLD THE CATHETER IN PLACE. IT WAS ALSO STATED THAT THE CUSTOMER WAS ONLY ABLE TO GET THE CATHETER INTO THE CLIP. DISCUSSED WITH THE CUSTOMER THAT THE DIAGRAM INDICATED THE CORRECT PLACE TO LIP THE STATLOCK (UNDER THE Y UNION AND ONLY ON THE LARGE CATHETER). THE CUSTOMER STATED THAT THEY WILL CALL BACK IF THE PROBLEM CONTINUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12401715 ↗
• MalfunctionAug 31, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT STATLOCK CATHETER STABILIZATION DEVICE WAS NOT STAYING CLOSED AND THREE OF THE FOUR LOCKING DEVICES HAD OPENED ON THEIR OWN. THE DEVICE CLICKED TO THE CLOSED POSITION, APPEARED TO BE SECURED AND THEN WHEN THE CUSTOMER CHECKED, THE LOCK HAD OPENED. THE PATIENT WAS PRIMARILY SEDENTARY. ALSO TO KEEP THE CATHETER IN PLACE, THE CUSTOMER HAD USED ELASTIC BANDAGE WRAP AND CLOTH TAPE TO HOLD THE LOCKING DEVICE IN PLACE TO PREVENT INADVERTENT INJURY. THE LOTS USED WERE JUDY2781, JUFP8111 AND JUFP8026, BUT CUSTOMER CANNOT ATTRIBUTE WHICH LOT WAS USED THAT WAS DEFECTIVE. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 26AUG2021, THE CUSTOMER HAD A NEW STATLOCK DEVICE THAT WAS WORKING AS INTENDED WHEN INITIALLY PLACED ON THE PATIENT, BUT SINCE HAD BEEN UNLOCKED THROUGHOUT THE DAY WHICH CAUSED DISCOMFORT WHEN THE CATHETER PULLED ON. THE CUSTOMER TOOK SECONDARY MEASURES TO KEEP THE INDWELLING CATHETER SECURED TO THEIR LEG SO IT DID NOT CAUSE ADDITIONAL INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12391816 ↗