Personal Catheter Intermittent CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 123
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 19 models of Personal Catheter Intermittent Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 123 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and Sep 23, 2026 — classified as 6 injuries, 117 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (28 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
Reports received per month, all models
Most reported Personal Catheter Intermittent Catheter problems
Device problems
- Product Quality Problem28
- Short Fill16
- Difficult to Insert14
- Component Missing13
- Improper Chemical Reaction12
- Device Operates Differently Than Expected10
- Material Integrity Problem8
- Component Misassembled7
Patient problems
- No Known Impact Or Consequence To Patient52
- No Consequences Or Impact To Patient30
- No Clinical Signs, Symptoms or Conditions21
- No Patient Involvement13
- Pain9
- No Information8
- Hemorrhage/Blood Loss/Bleeding6
- Patient Problem/Medical Problem6
Personal Catheter Intermittent Catheter models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Personal Catheter™ Intermittent Catheter 63614CATHETER, UROLOGICAL55 reports
- Personal Catheter™ Intermittent Catheter 63612CATHETER, UROLOGICAL16 reports
- Personal Catheter™ Intermittent Catheter 62608CATHETER, UROLOGICAL10 reports
- Personal Catheter™ Intermittent Catheter 63616CATHETER, UROLOGICAL8 reports
- Personal Catheter™ Intermittent Catheter 63618CATHETER, UROLOGICAL8 reports
- Personal Catheter™ Intermittent Catheter 61612CATHETER, UROLOGICAL5 reports
- Personal Catheter™ Intermittent Catheter 63316CATHETER, UROLOGICAL4 reports
- Personal Catheter™ Intermittent Catheter 63512CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Personal Catheter™ Intermittent Catheter 61314CATHETER, UROLOGICAL2 reports
- Personal Catheter™ Intermittent Catheter 62610CATHETER, UROLOGICAL2 reports
- Personal Catheter™ Intermittent Catheter 63318CATHETER, UROLOGICAL2 reports
- Personal Catheter™ Intermittent Catheter 61312CATHETER, UROLOGICAL1 report
- Personal Catheter™ Intermittent Catheter 61614CATHETER, UROLOGICAL1 report
- Personal Catheter™ Intermittent Catheter 61914CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Personal Catheter™ Intermittent Catheter 61916CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Personal Catheter™ Intermittent Catheter 61918CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Personal Catheter™ Intermittent Catheter 63312CATHETER, UROLOGICAL1 report
- Personal Catheter™ Intermittent Catheter 63314CATHETER, UROLOGICAL1 report
- Personal Catheter™ Intermittent Catheter 63514CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent Personal Catheter Intermittent Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873306 ↗MalfunctionDec 15, 2025Complete Blockage; Complete Blockage
IT WAS REPORTED THAT THE ONE INTERMITTENT CATHETER IN THE BOX WAS BLOCKED ALL THE WAY DOWN THE INTO THE TUBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23810477 ↗MalfunctionOct 22, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT DURING USE THE INTERMITTENT CATHETER WAS NOT WORKING WELL WERE OF BLUE COLOUR BUT THE ONES USED TO GET BEFORE OF GREEN COLOUR THAT WAS WORKING WELL. THE FLUID FOR LUBRICATION OF THE BLUE COLOURED CATHETER WAS NOT AS SMOOTH AS THE GREEN COLOURED OLD ONES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23357061 ↗MalfunctionOct 6, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THE PATIENT MENTIONED THAT SOME OF THE FOLEY CATHETERS IN THE PACKAGE WERE NOT LUBRICATED SO COULD NOT BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23222985 ↗MalfunctionSep 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT, WHEN HANDLING THE INTERMITTENT CATHETERS, IT WAS FOUND MOST OFTEN THAT A SLIGHT SLIT IN THE SKIN TO THE FINGERS. ON CLOSER EXAMINATION IT WAS FOUND THE EDGES OF THE SLEEVES HAD TINY SERRATIONS, SIMILAR TO A FILE OR EXTREMELY FINE CRAFT SAW, KNIFE BLADE. IT WAS RAZOR SHARP AND NOT EASY TO AVOID TOUCHING WHEN OPENING TO USE, OR TO PACK THE CATHETERS AWAY FOR DISPOSAL. USER FOUND THE USAGE VERY SPITEFUL AND UNCOMFORTABLE TO THE HANDS. CO-INCIDENTALLY, THIS HAD ONLY OCCURRED SINCE THE CHANGE FROM GREEN TO BLUE BOXES CONTAINING 30 CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort; Skin Tears
MAUDE report 23156186 ↗MalfunctionSep 22, 2025Wrong Label; Wrong Label
IT WAS REPORTED THAT THEY HAD AN INCIDENT WHERE A CUSTOMER HAD RECEIVED A 63612 INSIDE A BOX LABELED 73612, THEIR CUSTOMER SERVICE TEAM HAD SAID THE PRODUCT THEY USED TO GET WAS IN A BLUE BOX. THIS WAS IN A GREEN BOX, AND IT SAYS 73612 ON THE BOX AND THE INTERMITTENT CATHETERS BUT THE PACKETS CONTAIN SOMETHING VERY DIFFERENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23108962 ↗InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT STATED THAT THE LAST INTERMITTENT CATHETERS THAT WAS SENT OUT, WAS A DIFFERENT SIZE AND THEY HAD TO GET USED TO THAT AND THEN GAVE THEMSELVES A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 23083330 ↗MalfunctionSep 17, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT, THE HOLES IN THE FOLEY CATHETER HAD NOT BEEN CUT OUT PROPERLY. SCRAPES INSIDE THE URETHRA WHEN USING. IT HAD HAPPENED TO AT LEAST 2 OF THEM FROM THE SAME BOX AND CAUSED A LITTLE BLEEDING.
Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23073667 ↗MalfunctionSep 16, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT THE PATIENT ADVISED THAT THEY NOTICED THE PACKAGING CHANGED ON THE LAST ORDER AND THE PATIENT SAID THEY CHECKED THE CODES AND THE SAME, SO THEY USED THEM BUT FOUND SOME DIFFERENCES. THE PATIENT SAID THE INDIVIDUAL SLEEVES WERE CRAMMED TOGETHER AND HARD TO SEPARATE. PATIENT ALSO SAID THE EDGES OF THE SLEEVES WERE VERY SHARP AND THEY GOT A FEW CUTS FROM THEM.
Patient problems: Abrasion
MAUDE report 23065418 ↗MalfunctionSep 8, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT, A DOZEN OF INTERMITTENT CATHETERS FROM ONE PACK DID NOT HAD SUFFICIENT LUBRICATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22999308 ↗MalfunctionJul 3, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT, ON THE LAST ORDER CUSTOMER RECEIVED, MOST OF THE INTERMITTENT CATHETERS TO BE DISPOSED OF AS CATHETER WERE NOT LUBRICATED ENOUGH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22395566 ↗MalfunctionJul 1, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT PATIENT ADVISED THAT THE WHOLE BOX DID NOT HAD ENOUGH LUBRICANT IN IT TO BE ABLE TO USE THE INTERMITTENT CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373252 ↗MalfunctionJun 25, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT TWO INTERMITTENT CATHETERS FROM PREVIOUSLY DELIVERED WAS FULLY SOLID INSIDE CATHETER WITH NO DRAINAGE CHANNEL BORED THROUGH PRODUCT. NO DRAINAGE UPON INSERTION. ONLY 2 WERE AFFECTED, TOTAL 4 BOXES WERE SENT, REMAINING QUANTITY SUITABLE FOR USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328947 ↗MalfunctionMay 12, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE DURING USE, FOLLOWED BY REVIEW OF A PATIENT THEY HAD REPORTED ISSUE WITH PASSING THEIR HYDROSIL SIZE 8 CATHETER CODE 62608P FOR THE LAST 3 WEEKS. THESE WERE DELIVERED BY SCRIPTEASY DELIVERY COMPANY. WHEN THE ISSUE OCCURRED, THEY FELT THERE WAS A SIZE DISCREPANCY. AT THE CLINIC, CUSTOMER BROUGHT INTERMITTENT CATHETERS THAT DID VISUALLY APPEAR TO BE SLIGHTLY DIFFERENT. THEY WOULD BE GRATEFUL IF THEY WERE ABLE TO LOOK INTO THIS ISSUE FOR THEM. THEY HAVE THE FOLEY CATHETERS IF THEY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002491 ↗MalfunctionMay 5, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE HYDROSIL CATHETER SIZE HAD DISCREPANCY. PER ADDITIONAL RECEIVED ON 23APR2025, PARENTS STRUGGLED TO PASS THE CATHETER ON SEVERAL OCCASIONS AND NOTED SIZE DISCREPANCIES WITH THE CATHETERS. REQUIRED MULTIPLE ATTEMPTS TO CATHETERISE CHILD DUE TO ISSUES WITH CATHETER, FELT THINNER CATHETER WAS DIFFICULT TO PASS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21960341 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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