Catheter Stabilization Device FOL0100Recalls & reported problems

Summary

The FDA's MAUDE database contains 147 adverse event reports that list this exact device (DI 00801741076077), received between Jun 6, 2017 and Apr 9, 2026 — classified as 3 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Disconnection” (53 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 147 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT ON (B)(6) THE CUSTOMER RECEIVED ONE BOX CONTAINING 12 CATHETERS. THE CUSTOMER REPORTED THAT TWO UNITS WERE FAULTY AND EXHIBITED LEAKAGE AT THE TIME OF RECEIPT. NO ADDITIONAL INFORMATION REGARDING PATIENT USE OR ADVERSE EVENTS WAS REPORTED. DURING THE INITIAL CONTACT, THE FACILITY ASSOCIATES INQUIRED ABOUT THE POSSIBILITY OF SHIPPING REPLACEMENT PRODUCT TO THE CUSTOMER. IT WAS COMMUNICATED DURING THE CALL THAT A PRODUCT INVESTIGATION MUST BE COMPLETED BEFORE DETERMINING WHETHER REPLACEMENT PRODUCT CAN BE PROVIDED. THIS NOTE IS INCLUDED TO DOCUMENT THE REQUEST MADE DURING THE FIRST CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830221 ↗
• MalfunctionJun 30, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT TWO STATLOCK COULD NOT OPEN TO USE AND ALSO WHEN USING THE EDGES WERE SHARP. IT WAS AN ONGOING ISSUE, AND PATIENT WAS NOT ABLE TO USE. CUSTOMER WOULD LIKE REVAMP PRODUCT AND REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22358768 ↗
• MalfunctionJun 30, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT PATIENT WAS USING FOLEY STATLOCK (PCN # FOL0100) AND STATED THE CORNER OF THE PLASTIC PIECE WAS TOO SHARP FOR THE INSIDE OF THEIR THIGH. PATIENT ALSO STATED IT USUALLY WORKED WELL, BUT THERE HAD BEEN TWO ITEMS THAT ONCE THEY LOCKED, THEY COULD NOT GET THEM UNLOCKED. PATIENT TOOK THEM TO THEIR HEREDITARY COPROPORPHYRIA (HCP) AND THEY COULD NOT OPEN IT EITHER. REPRESENTATIVE EXPLAINED PROPER PLACEMENT OF FOLEY STATLOCK FROM IFU, IDENTIFY PROPER SECUREMENT SITE BY GENTLY LAYING THE STATLOCK¿ STABILIZATION DEVICE STRAIGHT ON THE FRONT OF THE THIGH. DISCUSSED POSSIBLY ADDING GAUZE TO THE STATLOCK TO PROTECT PATIENT INNER THIGH. SUGGESTED PATIENT HOLD ONTO THE STATLOCK THAT COULD NOT BE OPENED AS COMPLAINTS MIGHT WANT THIS BACK FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22357841 ↗
• MalfunctionApr 23, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT ONE OF PACKETS CAME EMPTY WITH NO STAT LOCK INSIDE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891774 ↗
• MalfunctionApr 22, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STATLOCK CLIP WAS FAULTY. PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON (B)(6) 2025, CUSTOMER CONFIRMED THAT THE CLIP OF THE STATLOCK WAS BROKEN. AND AFFECTED QUANTITY WAS 1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881846 ↗
• MalfunctionApr 15, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 12 EACH OF STATLOCK ORDERED THROUGH MCKESSON. THE CUSTOMER REPORTED ITEM WAS DEFECTIVE AND THEY WERE FALLING APART, AND THE OTHER ONE SNAPPED AND BROKE. THEY WERE USING THE 3RD ONE, AND IT WAS NOT HOLDING UP AS WELL THEY FELT SINCE THEY ALL HAVE THE SAME LOT, THEY ALL WERE BAD, AND THE CUSTOMER WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21841310 ↗
• MalfunctionSep 24, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT FOLEY STATLOCK FELL OFF AND AFTER 1 DAY THE CLAMP BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291145 ↗
• MalfunctionSep 5, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT 4 STATLOCKS BROKE WHILE TRYING TO USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20144697 ↗
• MalfunctionJun 25, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE CUSTOMER WAS USING A CLAMP TO CLAMP THE TUBE ON THE CATHETER AND THE CLAMP WAS PERFORATING THE TUBING. THEY HAD TO CUT OFF THE TEETH OF THE CLAMP AND IT WORKED FINE. CUSTOMER HAD SAMPLES TO RETURN IF NEEDED. THEY WOULD ALSO LIKE REPLACEMENTS. PER FOLLOW UP ON (B)(6) 2024, IT WAS REPORTED THAT THE TEETH OF THE STATLOCK ON THE INNER PART OF THE CLAMP POKED THROUGH THE CATHETER TUBING CAUSING IT TO CUT THROUGH IT. CUSTOMER CONFIRMED LOT NUMBER JUHR0558 FOR THE REPORTED PRODUCT. PRODUCT WAS BEING USED WHEN THE DEFECT WAS NOTICED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19604350 ↗
• MalfunctionFeb 9, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY STATLOCK PLASTIC WAS BREAKING OFF THE TAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18677250 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Device Handling Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE URINARY MEATUS INJURY WAS A DEVICE USE RELATED COMPLICATION THAT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION IN RELATION TO FOLEY STATLOCK. 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 18649277 ↗
• MalfunctionSep 25, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE STATLOCK BROKE IN LESS THAN 24HOURS OF WEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807265 ↗
• MalfunctionJul 5, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT CUSTOMER PURCHASED STATLOCK AND AFTER ON USE THE PLASTIC LATCH CAME OFF AFTER ONE SINGLE DAY USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259528 ↗
• MalfunctionJul 5, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT CUSTOMER HAVING TROUBLE WITH THE STATLOCK (FOL0100) (FOL0102) ON PATIENT CATHETER. PATIENT RECENTLY MOVED UP FROM UP TO 18FR LUBRISIL FOLEY CATHETER AND NOTICED THE OTHER DAY IT WAS PINCHING THE FOLEY TO THE POINT THAT THE URINE WAS COMING OUT FROM AROUND THE FOLEY (AT URETHRA SITE) (1758SI18). REPRESENTATIVE ADVISED OUR STATLOCKS ARE MADE TO FIT 6-26FR FOLEY CATHETERS. IF THE FOLEY CATHETER DID NOT FIT INTO THE STATLOCK@ FOLEY DEVICE CLAMP, THEN CHECK TO BE CERTAIN THE DIRECTIONAL ARROW ON THE RETAINER CLAMP WAS FACING THE TIP OF THE CATHETER AND THAT THE FOLEY ARMS WERE PLACED IN THE CORRECT CHANNELS. IF THE CATHETER STILL DID NOT FIT, PLACE ONLY THE BALLOON ARM INTO THE NARROW CHANNEL AND LEAVE THE OTHER ARM OUTSIDE OF THE CLAMP. CUSTOMER STATED THIS WAS THE FIRST TIME THIS HAD HAPPENED IN 8 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259242 ↗
• MalfunctionJun 14, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY STATLOCK BROKE AFTER USING IT FOR 2 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17125484 ↗
• MalfunctionMay 18, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT THE FOLEY STATLOCK DID NOT WORK, AND IT DID NOT CLOSE IN PLACE. REPRESENTATIVE ADVISED PATIENT WAS USING THE STATLOCK INCORRECTLY AND ADVISED ON PROPER USE. PER FOLLOW UP VIA PHONE ON 17MAY2023, IT WAS REPORTED THAT PATIENT WAS USING LATEX FOLEY, BUT THEY WERE SWITCHED TO A SILICONE FOLEY AND THE LATEX STATLOCK DID NOT FIT THE SILICONE FOLEY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16952418 ↗
• MalfunctionMar 30, 2023Fitting Problem; Difficult to Open or Close; Fitting Problem; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT WANTED TO KNOW WHY THEIR STATLOCK KEPT LOOSENING UP. THE PRODUCT WAS SUPPLIED BY HH AGENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644882 ↗
• MalfunctionMar 27, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUSTOMER HAD BEEN HAVING ISSUES GETTING THE COVIDIEN SILICONE FOLEYS TO FIT IN THE STATLOCK FOR THE PAST YEAR. ALSO STATED IF THEY FLIP THE FOLEY OVER, THE WHITE CIRCULAR PART PUSHED THE PATIENT AND WAS UNCOMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618534 ↗
• MalfunctionJan 31, 2023Disconnection; Disconnection

  IT WAS REPORTED THAT THE STATLOCKS FALL APART. THE PATIENT STATED THAT THEY HAD TO USE STRAPS TO HOLD IT. THEY OFFERED TO CHANGE THEM TO ANOTHER ONE AND THEY WERE OKAY WITH THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16272159 ↗
• MalfunctionNov 2, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY STAT LOCK HAS BEEN USED BY THE PATIENT FOR A LONG TIME. BUT THE LAST FOUR OR SO HAVE BEEN BREAKING NOT LONG AFTER APPLICATION. AS PER SAMPLE RECEIVED ON (B)(6) 2022, IT WAS NOTED THAT THE CUSTOMER RETURNED TWO FOLEY STATLOCK CATHETERS WITH (LOT# JUGT8059) AND (LOT# UNK) FOR EVALUATION. AS PER FOLLOW UP VIA PHONE ON (B)(6) 2022, CUSTOMER CONFIRMED THAT THEY WERE HAVING THE SAME ISSUES WITH BOTH LOTS (LOT# JUGT8059) AND (LOT# UNK). IT WAS STATED THAT THE STATLOCK WAS BREAKING OFF FROM BOTH AFTER PLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15714201 ↗
• MalfunctionOct 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE FOLEY STAT LOCK HAS BEEN USED BY THE PATIENT FOR A LONG TIME. BUT THE LAST FOUR OR SO HAVE BEEN BREAKING NOT LONG AFTER APPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579380 ↗
• MalfunctionSep 29, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE METAL PART HAD BEEN PULLED FROM THE CENTER PART OF THE STATLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15503027 ↗
• MalfunctionSep 20, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HAVING ISSUES WITH THE FOLEY STATLOCK DEVICE SECURING 14FR FOLEY CATHETERS. STATED THAT THEY USED FOLEY STATLOCK PEDIATRIC FOR SIL CATH (VFDSSP) AND FOLEY STATLOCK ADLT FOR SIL CATH (FOL0100). STATED THAT THEY WERE HAVING ISSUES WHEN USING WITH THE 14FR CATHETER, IT WOULD CLOSE, BUT IT DID NOT LATCH PROPERLY AND COULD POP OPEN ( PCN# VFDSSP) AND ( PCN# FOL0100), AND ALSO STATED THAT THE ONE CATHETER UNABLE TO FIT AT ALL (PCN# VFDSSP) AND ( PCN# FOL0100).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455208 ↗
• MalfunctionSep 20, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WERE 2 INCIDENTS ON APR AND MAY WHERE THE FOLEY STATLOCK DID NOT STAY CLIPPED AROUND THE CATHETER TUBING AND STATED THAT THE NURSE CHANGED THE STATLOCK APPROXIMATELY EVERY 4 WEEKS. PER INVESTIGATOR NOTIFICATION ON (B)(6) 2022, STATED THAT THE CUSTOMER RETURNED 3 ADDITIONAL STABILIZATION DEVICES THAT WERE USED. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2022, IT WAS FOUND THAT THE CLAMP WAS DISCONNECTED FROM THE SWIVEL BASE DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455092 ↗
• MalfunctionSep 20, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE SUPRAPUBIC CATHETER¿S STOP WORKING AFTER ABOUT A WEEK OF USE LAST LESS THAN A MONTH VERSES, THEY USED TO WORK WELL FOR UP TO A YEAR. STATED THAT THE FOLEY STATLOCK RUBBER LIKE MATERIAL COMES LOOSE OR EITHER ADHESIVE DID NOT STAY ATTACHED TO LEG PAST A WEEK . AND THEY WERE ABOUT 6 OTHER CATHETERS THAT DID NOT FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455089 ↗