Catheter Stabilization Device FOL0102Recalls & reported problems

Summary

The FDA's MAUDE database contains 375 adverse event reports that list this exact device (DI 00801741076114), received between Apr 21, 2017 and Sep 19, 2025 — classified as 12 injuries, 363 malfunctions.

The most frequently reported specific device problem is “Disconnection” (155 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 375 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE PATIENT SAID THE STAT LOCK HOLDERS ARE TOO SMALL. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096401 ↗
• MalfunctionSep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT, PATIENT HAD A REACTION TO THE FOLEY STATLOCK AFTER REMOVING. PATIENT HAD CAME UP WITH A RAISED STRONG LINE RED MARK, IRRITATION TO THE SKIN. IT WAS ADVISED IT MIGHT BE DUE TO PUTTING IT IN THE SAME PLACE AS THE PREVIOUS STATLOCK. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Local Reaction; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 23084115 ↗
• MalfunctionJul 2, 2025Material Split, Cut or Torn; Sharp Edges; Material Split, Cut or Torn; Sharp Edges

  IT WAS REPORTED THAT THE NURSE AT HOSPITAL THINKS THAT THE FOLEY STATLOCKS HAD CAUSED A HOLE IN CATHETERS. IT WAS REPORTED THAT ALSO RAISED COMPLAINT AGAINST THE FOLEY CATHETERS TOO JUST IN CASE THE PATIENT HAD 3 CHANGED WITH IN THE PAST WEEK POTENTIALLY DUE TO A HOLE. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 13JUN2025, STATED THAT THE PATIENT DID NOT KNOW IF THE ISSUE WAS WITH THE FOLEY STATLOCKS FOR WHICH THE CATHETER HOLE WAS OCCURRING OR IT WAS THE CATHETER'S FAULT, THE NURSE JUST SUSPECTED IT WAS THE STATLOCK CAUSING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22384661 ↗
• MalfunctionMay 13, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WERE SHARP PROTRUSIONS ON FOLEY STATLOCK DEVICE POSSIBLY CAUSING DAMAGE ON CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010333 ↗
• InjuryMay 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE WOUND CARE TEAM HAD ASKED THEM TO REACH OUT ABOUT THE STAT LOCK. THEY HAD 2 UNSTAGEABLE PRESSURE INJURIES ASSOCIATED WITH THESE DEVICES IN 2025. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 21977219 ↗
• MalfunctionApr 25, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED STATLOCK FOLEY SEALED PACKAGING WITHOUT THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909688 ↗
• MalfunctionApr 24, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER REPORTED ONE OF THE FOLEY STATLOCK CATHETERS SNAPPED WHEN THEY ATTEMPTED TO USE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21900345 ↗
• MalfunctionFeb 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER STATED THAT STATLOCK FIXATOR CLIP KEEPS BREAKING. 2 PRODUCTS WERE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21458802 ↗
• MalfunctionDec 2, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT CUSTOMER RECEIVED A DAMAGE FOLEY STATLOCK CLIP WHERE THE CLIP WAS BROKEN. PER FOLLOW UP VIA EMAIL ON 14JAN2025, CUSTOMER REPORTED THAT THE DEVICE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819544 ↗
• MalfunctionOct 3, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PATIENT ADVISED THAT THE CLIP ON THE STATLOCK BROKE OFF AT THE PLASTER PART IN THE NIGHT. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 16SEP2024, CUSTOMER CONFIRMED THAT THE CLIP WAS BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359378 ↗
• MalfunctionSep 6, 2024Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS OBSTRUCTED DUE TO THE TWISTING OF THE CATHETER. IT WAS LIKELY RELATED TO RESIDENTS WITH SOME COGNITIVE IMPAIRMENTS MANIPULATING THIS DEVICE. END USER FEEDBACK STATED THAT PERHAPS A 180-DEGREE TURN (VS 360-DEGREE) MAY LESSEN THE CHANCE OF THIS OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156846 ↗
• MalfunctionApr 16, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY STATLOCK CLASP AT THE TOP OF THE BAG WHERE IT ATTACHED TO LEG, HAD BROKEN OFF ON 3 BAGS OUT OF THE SAME CASE. CUSTOMER HAD ANOTHER CASE THAT THEY GAVE THE LOT# OF, BUT THEY DID NOT KNOW IF IT WAS THE SAME LOT# AS THE BOX THAT HAD THE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19114945 ↗
• MalfunctionApr 12, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN OPENING THE STATLOCK, THE PRODUCT WAS BROKEN AND DID NOT CLOSE THE PROBE HOLDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095544 ↗
• MalfunctionJan 24, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT PATIENT WAS USING STATLOCK WITH FOLEY CATHETER AS A SUPRAPUBIC CATHETER. PATIENT¿S CATHETER FELL OUT; THE HOSPITAL REPLACED THE CATHETER AND INFORMED THAT THE BALLOON DEFLATED DUE TO A HOLE CAUSED BY THE STATLOCK. PATIENT STATES CATHETER PINCH-HOLE OCCURRED AT THE BIFURCATION POINT ON THE SWIVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18571720 ↗
• MalfunctionNov 27, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SOME OF THESES FOLEY STATLOCK WERE BROKEN AS WELL THE PATIENT PROVIDED LOT # JUHU0699. THE REPRESENTATIVE ADVISED THE PATIENT WOULD REPLACE 7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18209016 ↗
• InjuryNov 1, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT STATED THESE FOLEY STATLOCK CAUSED SKIN IRRITATION. THE PATIENTS DOCTOR INFORMED NOT ALLERGIC TO LATEX, PRESCRIBED MEDICATION AND PROVIDED ADDITIONAL ADHESIVE STRIPS.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18046882 ↗
• MalfunctionAug 25, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT ADHESIVE PATCH THAT HOLDS CATHETER ON LEG, THE FASTENER OPENED EVENTUALLY AND WOULD NOT SNAP BACK ON. ONLY LASTED A COUPLE OF HOURS. WENT TO EMERGENCY ROOM AND PUT ANOTHER ONE IN AND LASTED ABOUT 12 HOURS. AND WENT TO UROLOGIST TO GET ANOTHER AND ONLY LASTED A DAY OR SO. SENT HOME WITH 2 OF THEM, PUT ON THEM SELF AND LASTED A DAY OR SO. PER FOLLOW UP VIA PHONE ON 09 AUG 2023, IT WAS REPORTED THAT THEY HAD AN INTERMITTENT CATHETER IN FOR 10 DAYS AND THE SEVERAL STATLOCKS THEY USED WOULD FALL OFF COMPLETELY IF ANY TENSION CAME TO THE STATLOCKS. THEY SPOKE WITH THEIR UROLOGIST TO FIND ALTERNATIVES OR SUBSTITUTES, BUT THEY FELT THE CLASP WAS NOT THE RIGHT FIT FOR THE CATHETERS, THEY USED THEM WITH AND ALSO IT MADE NOTE THAT SOME SLIGHT IRRITATION OCCURRED WHERE THE STATLOCKS WERE PLACED AND TRYING TO ALLEVIATE THE SORENESS. THE CUSTOMER MADE IT CLEAR THAT THEY MERELY REPORTING THEIR EXPERIENCE WITH THE STATLOCKS AND HAS NO FURTHER INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622729 ↗
• MalfunctionAug 24, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ADHESIVE PATCH THAT HOLDS CATHETER ON LEG, THE FASTENER OPENED EVENTUALLY AND WOULD NOT SNAP BACK ON. ONLY LASTED A COUPLE OF HOURS. WENT TO EMERGENCY ROOM AND PUT ANOTHER ONE IN AND LASTED ABOUT 12 HOURS. AND WENT TO UROLOGIST TO GET ANOTHER AND ONLY LASTED A DAY OR SO. SENT HOME WITH 2 OF THEM, PUT ON THEMSELVES AND LASTED A DAY OR SO . PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THEY HAD AN INTERMITTENT CATHETER IN FOR 10 DAYS AND THE SEVERAL STATLOCKS THEY USED WOULD FALL OFF COMPLETELY IF ANY TENSION CAME TO THE STATLOCKS. THEY SPOKE WITH THEIR UROLOGIST TO FIND ALTERNATIVES OR SUBSTITUTES, BUT THEY FELT THE CLASP WAS NOT THE RIGHT FIT FOR THE CATHETERS, THEY USED THEM WITH AND ALSO IT MADE NOTE THAT SOME SLIGHT IRRITATION OCCURRED WHERE THE STATLOCKS WERE PLACED AND TRYING TO ALLEVIATE THE SORENESS. THE CUSTOMER MADE IT CLEAR THAT THEY MERELY REPORTING THEIR EXPERIENCE WITH THE STATLOCKS AND HAS NO FURTHER INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17610755 ↗
• MalfunctionAug 23, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT ADHESIVE PATCH THAT HOLDS CATHETER ON LEG, THE FASTENER OPENED EVENTUALLY AND WOULD NOT SNAP BACK ON. ONLY LASTED A COUPLE OF HOURS. WENT TO EMERGENCY ROOM AND PUT ANOTHER ONE IN AND LASTED ABOUT 12 HOURS. AND WENT TO UROLOGIST TO GET ANOTHER AND ONLY LASTED A DAY OR SO. SENT HOME WITH 2 OF THEM, PUT ON THEM SELF AND LASTED A DAY OR SO. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THEY HAD AN INTERMITTENT CATHETER IN FOR 10 DAYS AND THE SEVERAL STATLOCKS THEY USED WOULD FALL OFF COMPLETELY IF ANY TENSION CAME TO THE STATLOCKS. THEY SPOKE WITH THEIR UROLOGIST TO FIND ALTERNATIVES OR SUBSTITUTES, BUT THEY FELT THE CLASP WAS NOT THE RIGHT FIT FOR THE CATHETERS, THEY USED THEM WITH AND ALSO IT MADE NOTE THAT SOME SLIGHT IRRITATION OCCURRED WHERE THE STATLOCKS WERE PLACED AND TRYING TO ALLEVIATE THE SORENESS . THE CUSTOMER MADE IT CLEAR THAT THEY MERELY REPORTING THEIR EXPERIENCE WITH THE STATLOCKS AND HAS NO FURTHER INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17602913 ↗
• MalfunctionAug 18, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ADHESIVE PATCH THAT HOLDS CATHETER ON LEG, THE FASTENER OPENED EVENTUALLY AND WOULD NOT SNAP BACK ON. ONLY LASTED A COUPLE OF HOURS. WENT TO EMERGENCY ROOM AND PUT ANOTHER ONE IN AND LASTED ABOUT 12 HOURS. AND WENT TO UROLOGIST TO GET ANOTHER AND ONLY LASTED A DAY OR SO. SENT HOME WITH 2 OF THEM, PUT ON THEMSELF AND LASTED A DAY OR SO. PER FOLLOW UP VIA PHONE ON (B)(6)2023, IT WAS REPORTED THAT THEY HAD AN INTERMITTENT CATHETER IN FOR 10 DAYS AND THE SEVERAL STATLOCKS THEY USED WOULD FALL OFF COMPLETELY IF ANY TENSION CAME TO THE STATLOCKS. THEY SPOKE WITH THEIR UROLOGIST TO FIND ALTERNATIVES OR SUBSTITUTES, BUT THEY FELT THE CLASP WAS NOT THE RIGHT FIT FOR THE CATHETERS, THEY USED THEM WITH AND ALSO IT MADE NOTE THAT SOME SLIGHT IRRITATION OCCURRED WHERE THE STATLOCKS WERE PLACED AND TRYING TO ALLEVIATE THE SORENESS. THE CUSTOMER MADE IT CLEAR THAT THEY MERELY REPORTING THEIR EXPERIENCE WITH THE STATLOCKS AND HAS NO FURTHER INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17572342 ↗
• MalfunctionAug 17, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ADHESIVE PATCH THAT HOLDS CATHETER ON LEG, THE FASTENER OPENED EVENTUALLY AND WOULD NOT SNAP BACK ON. ONLY LASTED A COUPLE OF HOURS. WENT TO EMERGENCY ROOM AND PUT ANOTHER ONE IN AND LASTED ABOUT 12 HOURS. AND WENT TO UROLOGIST TO GET ANOTHER AND ONLY LASTED A DAY OR SO. SENT HOME WITH 2 OF THEM, PUT ON HIMSELF AND LASTED A DAY OR SO. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THEY HAD AN INTERMITTENT CATHETER IN FOR 10 DAYS AND THE SEVERAL STATLOCKS THEY USED WOULD FALL OFF COMPLETELY IF ANY TENSION CAME TO THE STATLOCKS. THEY SPOKE WITH THEIR UROLOGIST TO FIND ALTERNATIVES OR SUBSTITUTES, BUT THEY FELT THE CLASP WAS NOT THE RIGHT FIT FOR THE CATHETERS, THEY USED THEM WITH AND ALSO IT MADE NOTE THAT SOME SLIGHT IRRITATION OCCURRED WHERE THE STATLOCKS WERE PLACED AND TRYING TO ALLEVIATE THE SORENESS. THE CUSTOMER MADE IT CLEAR THAT THEY MERELY REPORTING THEIR EXPERIENCE WITH THE STATLOCKS AND HAS NO FURTHER INFORMATION TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17568206 ↗
• MalfunctionAug 4, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE PLASTIC CLAMP WAS NOT HOLDING THE TUBE, THE CLAMP WAS BREAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17466719 ↗
• MalfunctionJul 26, 2023Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; Difficult to Open or Close

  IT WAS REPORTED THAT THE FOLEY STATLOCK ROTATES 360 DEGREE WHICH KINKS THE FOLEY CATHETER PREVENTING URINE FROM DRAINING AND PULLING AT PATIENTS URETHRA. IT WAS STATED THAT THE USER WOULD LIKE A PRODUCT THAT DID NOT ROTATE OR ONLY ROTATE 180 DEGREE. IT WAS NOTED THAT THE PRODUCT WAS AVAILABLE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398926 ↗
• MalfunctionJul 19, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT SWIVEL LOCK CAME OFF EASILY WITH THE LATEST TWO SHIPMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349932 ↗
• MalfunctionJul 18, 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 17344393 ↗