Catheter Stabilization DeviceRecalls & reported problems across all models

We found 7 models of Catheter Stabilization Device by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 803 adverse event reports in the FDA's MAUDE database, received between Apr 21, 2017 and Aug 26, 2026 — classified as 1 death, 24 injuries, 778 malfunctions.

The most frequently reported specific device problem is “Disconnection” (361 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Catheter Stabilization Device problems

Catheter Stabilization Device models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Catheter Stabilization Device FOL0102

  HOLDER, URETERAL CATHETER
  375 reports
• Catheter Stabilization Device FOL0101

  HOLDER, URETERAL CATHETER
  240 reports
• Catheter Stabilization Device FOL0100

  HOLDER, URETERAL CATHETER
  147 reports
• Catheter Stabilization Device FOL0105

  HOLDER, URETERAL CATHETER
  24 reports
• Catheter Stabilization Device NG0120

  DEVICE, INTRAVASCULAR CATHETER SECUREMENT
  1 death13 reports
• Catheter Stabilization Device VFDSSP

  HOLDER, URETERAL CATHETER
  3 reports
• Catheter Stabilization Device VFDSP

  HOLDER, URETERAL CATHETER
  1 report

Recent Catheter Stabilization Device adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459866 ↗
• MalfunctionAug 24, 2026Loss of or Failure to Bond

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420780 ↗
• 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 ↗
• MalfunctionOct 15, 2025Loss of or Failure to Bond; Component Misassembled; Loss of or Failure to Bond; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT REPEATEDLY, THE ADHESIVE LIFTS FROM THE NOSE AND PEELS BACK AFTER 4 HOURS, THE TAPE STICKS TO ITSELF WHEN YOU WRAP IT AROUND THE NASOGASTRIC BUT THEN THE TUBE SLIDES THROUGH IT. THIS WAS A HUGE RISK AS IT ALLOWS THE TUBE TO SLIDE OUT, INCREASING THE RISK OF ASPIRATION OF THE TUBE FEED AND ALSO THE LOSS OF A TUBE AS IT CAN SLIP OUT AND REQUIRE A NEW ONE TO BE REINSERTED. THIS ISSUE WAS REPORTED BY 6 DIFFERENT NURSES OVER THE PAST FEW DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23278019 ↗
• MalfunctionOct 8, 2025Device Dislodged or Dislocated; Component Misassembled; Device Dislodged or Dislocated; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER STATED THAT REPEATEDLY, THE ADHESIVE LIFTS FROM THE NOSE AND PEELS BACK AFTER 4 HOURS, THE TAPE STICKS TO ITSELF WHEN THEY WRAP IT AROUND THE NASOGASTRIC, BUT THEN THE TUBE SLIDES THROUGH IT. THIS WAS A HUGE RISK AS IT ALLOWS THE TUBE TO SLIDE OUT, INCREASING THE RISK OF ASPIRATION OF THE TUBE FEED AND ALSO THE LOSS OF A TUBE AS IT COULD SLIP OUT AND REQUIRE A NEW ONE TO BE REINSERTED, THIS ISSUE WAS REPORTED BY 6 DIFFERENT NURSES OVER THE PAST FEW DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23246736 ↗
• 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 ↗
• 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 ↗
• MalfunctionSep 10, 2025Device Damaged Prior to Receipt by User; Component Missing; Device Damaged Prior to Receipt by User; Component Missing

  IT WAS REPORTED THAT THE CUSTOMER HAD AS A BACKUP, THE NOTIFICATION OF THE WAREHOUSE AREA SINCE 1 PIECE OF THE STATLOCK WAS MISSING THAT CORRESPONDS TO THE INVOICE 9019864213 TO PLEASE SUPPORT US WITH THE FOLLOW-UP OF THE MISSING PIECE. THE PRODUCT WAS BACK LABELED IN THE CEDIS AT THE CJ LEVEL, BUT NOT AT THE PIECE LEVEL AND 1 EA WAS MISSING, IT WAS OF QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016087 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other C. R. Bard, Inc. products

• Bardex I.C. Foley Catheter26 models · 3,607 reports
• Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
• Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
• Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
• Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
• Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
• PureWick Female External Catheter5 models · 1,184 reports
• Bardex All-Silicone Foley Catheter12 models · 1,170 reports