Magic3™ Intermittent Catheter 51616Recalls & reported problems
C. R. Bard, Inc. · Magic3™ Intermittent Hydrophilic Coated Silicone, Female · Class 2
All models of Magic3 Intermittent Catheter (37)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741068256), received between May 23, 2017 and May 29, 2025 — classified as 1 injury, 11 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem4
- Difficult to Insert3
- Material Integrity Problem3
- Short Fill2
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Component Misassembled1
- Failure to Advance1
Patient problems
- No Known Impact Or Consequence To Patient5
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient3
- Discomfort1
- No Information1
- Urinary Tract Infection1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 29, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE INTERMITTENT CATHETER TIPS WERE CURVE AND SHARP WHEN USING ITEM. THE PATIENT WAS UNCOMFORTABLE WHEN USING ITEM DUE TO IT BEING SHARP AT THE END. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS NOTED THAT THE GIVEN LOT# WAS JUJV0730. CUSTOMER RESPONDED VIA EMAIL ON 30JUL2025, AND IT WAS REPORTED THAT THE PATIENT DISCARDED THE SAMPLE AFTER HOLDING IT FOR 30 DAYS, THEREFORE NO SAMPLE IS AVAILABLE. NO PATIENT HARM WAS REPORTED, BUT PATIENT WAS A BIT UNCOMFORTABLE WHEN TRYING TO USE ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22105981 ↗MalfunctionMay 29, 2025Sharp Edges; Sharp Edges
IT WAS REPORTED THAT THE INTERMITTENT CATHETER TIPS WERE CURVE AND SHARP WHEN USING ITEM. THE PATIENT WAS UNCOMFORTABLE WHEN USING ITEM DUE TO IT BEING SHARP AT THE END. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS NOTED THAT THE GIVEN LOT# WAS JUJV0730. CUSTOMER RESPONDED VIA EMAIL ON 30JUL2025, AND IT WAS REPORTED THAT THE PATIENT DISCARDED THE SAMPLE AFTER HOLDING IT FOR 30 DAYS, THEREFORE NO SAMPLE IS AVAILABLE. NO PATIENT HARM WAS REPORTED, BUT PATIENT WAS A BIT UNCOMFORTABLE WHEN TRYING TO USE ITEM.
Patient problems: Discomfort
MAUDE report 22104702 ↗MalfunctionMar 5, 2024Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THEY DID A STRAIGHT STICK TO A PATIENT 3 TIME TO SEE THAT THE CATHETER HAD NO HOLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18835862 ↗MalfunctionMar 24, 2023Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICANT ON THE MAGIC 3 FEMALE INTERMITTENT CATHETER. PATIENT HAD TO GO AND BUY THE LUBE TO USE WITH THE CATHETER. PER CLARIFICATION MAIL RECEIVED FROM LIBERATOR ON 22MAR2023, STATED THAT THE PATIENT WAS A MAN AND HE USES FEMALE-LENGTH INTERMITTENT CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16610153 ↗MalfunctionSep 17, 2021Short Fill; Short Fill
IT WAS REPORTED THAT 2 OF THE INTERMITTENT CATHETERS IN THE BOX DID NOT HAVE ANY STERILE WATER IN THE WATER SACHET. THE PATIENT STATED THAT THEY WERE NOT GOING TO PURSUE A REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12489512 ↗MalfunctionJul 28, 2020Inaccurate Flow Rate; Appropriate Device Problem Term/Code Not Available; Inaccurate Flow Rate
IT WAS REPORTED THAT THE PATIENT HAD TO WIGGLE THE CATHETER AROUND ONCE ITS INSERTED AND THEN IT WOULD DRAIN PATIENT'S BLADDER.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 10333630 ↗InjuryFeb 13, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE UTIS SINCE SHE STARTED USING THE CATHETERS.
Patient problems: Urinary Tract Infection
MAUDE report 9706816 ↗MalfunctionJul 11, 2018Short Fill; Material Integrity Problem
IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY, SINCE THE WATER SACHETS DID NOT HAVE THE PROPER AMOUNT OF WATER IN THEM.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7679518 ↗MalfunctionJun 15, 2018Difficult to Insert; Product Quality Problem
IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY AND WAS THEREFORE DIFFICULT TO INSERT.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 7606475 ↗MalfunctionMay 23, 2018Difficult to Insert; Product Quality Problem; Material Integrity Problem; Product Quality Problem
IT WAS REPORTED THAT THE LUBRICANT ON THE CATHETER WAS OF A THICKER CONSISTENCY THAN USUAL. THE PATIENT WAS ALLEGEDLY UNABLE TO FULLY INSERT THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7536754 ↗MalfunctionMay 23, 2018Difficult to Insert; Product Quality Problem; Material Integrity Problem; Product Quality Problem
IT WAS REPORTED THAT THE LUBRICANT ON THE CATHETER WAS OF A THICKER CONSISTENCY THAN USUAL, THEREFORE THE PATIENT WAS UNABLE TO FULLY INSERT THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7536686 ↗MalfunctionMay 23, 2017Product Quality Problem; Failure to Advance
IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY, ALLEGEDLY THE CATHETER WAS UNABLE TO BE INSERTED INTO THE PATIENTS BLADDER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6586232 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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