Magic3 Intermittent Catheter with Sure-Grip SleeveRecalls & reported problems across all models
C. R. Bard, Inc. · 14 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,310
- Deaths reported
- 0
- Injuries reported
- 174
- Recalls
- 0
We found 14 models of Magic3 Intermittent Catheter with Sure-Grip Sleeve by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,310 adverse event reports in the FDA's MAUDE database, received between Apr 7, 2017 and Sep 26, 2026 — classified as 174 injuries, 1,136 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (186 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 Magic3 Intermittent Catheter with Sure-Grip Sleeve problems
Device problems
- Product Quality Problem186
- Improper Chemical Reaction154
- Difficult to Insert136
- Short Fill129
- Component Missing106
- Material Integrity Problem100
- Material Twisted/Bent92
- Incorrect Measurement89
Patient problems
- No Known Impact Or Consequence To Patient425
- No Clinical Signs, Symptoms or Conditions338
- No Consequences Or Impact To Patient331
- Urinary Tract Infection126
- Pain106
- No Patient Involvement79
- Discomfort63
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available59
Magic3 Intermittent Catheter with Sure-Grip Sleeve models
14 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GCATHETER, UROLOGICAL692 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GCATHETER, UROLOGICAL301 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53612GCATHETER, UROLOGICAL161 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53514GCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES53 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 52608GCATHETER, UROLOGICAL20 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53618GCATHETER, UROLOGICAL20 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53516GCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES18 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53610GCATHETER, UROLOGICAL16 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53512GCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES13 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 52610GCATHETER, UROLOGICAL5 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53620GCATHETER, UROLOGICAL4 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 52606GCATHETER, UROLOGICAL3 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53518GCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53520GCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
Recent Magic3 Intermittent Catheter with Sure-Grip Sleeve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 26, 2026Difficult to Insert
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50908455 ↗MalfunctionApr 8, 2026Component Misassembled
IT WAS REPORTED THAT THE PRODUCT HAD BEEN USED FOR YEARS. IN THE CURRENT LOT, THREE CATHETERS WERE FOUND WITHOUT EYELET HOLES. THREE OUT OF THIRTY WAS CONSIDERED A SIGNIFICANT AMOUNT. THIS WAS THE FIRST OCCURRENCE OF THIS ISSUE, AND THE CONCERN WAS REPORTED TO MAKE THE ISSUE KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24816057 ↗MalfunctionApr 2, 2026Incorrect Measurement
IT WAS REPORTED THAT THE CUSTOMER STATES THAT THE RH53614G ARE TOO BIG, HE NEEDS 12FR. PATIENT HAS ORDERED THIS PRODUCT PREVIOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24766784 ↗MalfunctionMar 9, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT STATED THAT THE CATHETERS IN THE MANUFACTURER'S BOX WERE TWISTED AND BENT. NO ADDITIONAL INFORMATION PROVIDED. PATIENT HAS USED THIS PRODUCT BEFORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553219 ↗MalfunctionJan 23, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT SAID THAT SOME ARE PACKED TOO TIGHT AND SOME ARE DAMAGED BENT UP. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172969 ↗MalfunctionJan 2, 2026Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT SAID THE BOX IS SMALL, SO THEY GET BENT SOMETIMES, 5 IN ONE BOX ARE BENT. 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 23951655 ↗MalfunctionDec 19, 2025Material Twisted/Bent; Material Twisted/Bent
PATIENT SAID SOMETIMES GETS CATHETERS THAT HAVE NO OR VERY LITTLE WATER IN THE BURST PACK. HAS HAD A FEW THAT ARE TWISTED. 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 23857709 ↗MalfunctionDec 11, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PATIENT STATED THAT PACKAGING HAS DEFECTS WHERE HOLES ARE CREATED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23778288 ↗InjuryDec 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT THAT THE PATIENT MENTIONED THE BLEEDING AGAIN THAT HE STATED BEFORE. ONCE HE PUT IN THE COUDE CATH, HE HAD BLEEDING. HE DIDN'T KNOW IT WAS A COUDE CATH AND HAD TO GO TO THE HOSPITAL TO HAVE ALL THE BLOOD DRAINED OUT OF HIS BLADDER. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23770026 ↗MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE CUSTOMER WAS REACHING OUT BECAUSE THEY HAVE NOTICED ONGOING ISSUES WITH THE CATHETERS THEY RECEIVED. THE SIZES HAVE BEEN INCONSISTENT FROM ONE CATHETER TO ANOTHER, EVEN THOUGH THEY WERE LABELED AS THE SAME SIZE. THIS INCONSISTENCY WAS CAUSING DISCOMFORT AND MAKING IT DIFFICULT TO USE THEM SAFELY AND PROPERLY. THEY WOULD APPRECIATE IT IF THEY COULD LOOK INTO THIS ISSUE AND ADVISE ON HOW IT COULD BE RESOLVED.
Patient problems: Discomfort
MAUDE report 23639923 ↗MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE CUSTOMER WAS REACHING OUT BECAUSE THEY HAVE NOTICED ONGOING ISSUES WITH THE CATHETERS THEY RECEIVED. THE SIZES HAVE BEEN INCONSISTENT FROM ONE CATHETER TO ANOTHER, EVEN THOUGH THEY WERE LABELED AS THE SAME SIZE. THIS INCONSISTENCY WAS CAUSING DISCOMFORT AND MAKING IT DIFFICULT TO USE THEM SAFELY AND PROPERLY. THEY WOULD APPRECIATE IT IF THEY COULD LOOK INTO THIS ISSUE AND ADVISE ON HOW IT COULD BE RESOLVED. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort
MAUDE report 23639866 ↗MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE PATIENT HAS NOTICED A MORE SIGNIFICANT CURVE TO THE INTERMITTENT CATHETERS THAN NORMAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23604469 ↗MalfunctionNov 13, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE FLATTENED AND HAD POINTY TIPS. THEY WERE UNCOMFORTABLE DURING INSERTION BUT DID NOT CAUSE INJURY. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort
MAUDE report 23545817 ↗MalfunctionNov 13, 2025Collapse; Collapse
IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE FLATTENED AND HAD POINTY TIPS. THEY WERE UNCOMFORTABLE DURING INSERTION BUT DID NOT CAUSE INJURY. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort
MAUDE report 23545042 ↗MalfunctionNov 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT INTERMITTENT CATHETER WAS DAMAGED WITH BLACK STAINS INSIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490133 ↗
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
- 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
- PureWick Urine Collection System3 models · 1,096 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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