Magic3™ Intermittent Catheter 51614Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 00801741068249), received between Jun 28, 2017 and Jul 7, 2025 — classified as 12 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Component Missing” (9 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Component Missing; Component Missing

  IT WAS REPORTED BY PATIENT THAT ABOUT THE THREE OVER THE COURSE OF A YEAR, HER MAGIC3 CATHETER BOXES WOULD HAVE PACKAGES THAT HAD CATHETERS MISSING FROM INSIDE OF THEM. SHE STATED THAT SHE JUST WANTED US TO KNOW NOT REALLY A BID DEAL THOUGH. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412710 ↗
• MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAJORITY BOXES OF THE INTERMITTENT CATHETERS WERE COMPLETELY BENT, AND THE PATIENT EVEN FOUND A LOT OF BLACK SPECKS IN ONE OF THE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266365 ↗
• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD AN UNEVEN COATING OF HYDRPHILIC SURFACE, AND SOME AREAS WERE DRY, NOT SLIPPERY, BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092486 ↗
• MalfunctionOct 10, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT 4 PACKETS OF THE INTERMITTENT CATHETERS DID NOT HAVE THE CATHETER, ONLY THE LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20421383 ↗
• MalfunctionApr 29, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT SOMETIMES HAD PAIN WHILE USING THE INTERMITTENT CATHETER. PER FOLLOW UP VIA PHONE ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WHILE REMOVING THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 19200533 ↗
• MalfunctionJun 5, 2023Inadequate or Insufficient Training; Inadequate Instructions for Non-Healthcare Professional; Inadequate or Insufficient Training; Inadequate Instructions for Non-Healthcare Professional

  IT WAS REPORTED THAT THE PATIENT DID NOT UNDERSTAND HOW TO USE THE HYDROPHILIC INTERMITTENT CATHETERS. REPRESENTATIVE WAS ABLE TO EXPLAIN HOW TO USE THE HYDRO CATHETERS BUT THEY STILL SEEMED CONFUSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059475 ↗
• InjuryApr 2, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS BEEN HAVING URINARY TRACT INFECTION, BUT IT WAS UNSURE IF IT WAS BEING CAUSED BY THE MAGIC 3 INTERMITTENT CATHETER. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THAT TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 11610160 ↗
• InjuryAug 21, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION WITH THE USE OF THE INTERMITTENT CATHETER AND PREFERRED BAR51814. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 05AUG2020, THE PATIENT DEVELOPED A URINARY TRACT INFECTION FOLLOWING USE OF THE MAGIC 3 CATHETER. THE INFECTION WAS REPORTEDLY TREATED WITH ANTIBIOTICS.

  Patient problems: Irritation; Urinary Tract Infection

  MAUDE report 10439870 ↗
• InjuryAug 6, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE THAT THE PATIENT HAD TWO URINARY TRACT INFECTION SINCE JUNE. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10375991 ↗
• InjuryJul 31, 2020Improper or Incorrect Procedure or Method; Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT USED FEWER INTERMITTENT CATHETERS THAN NORMAL DUE TO BACKORDER AND AS A RESULT HAD GOT URINARY TRACT INFECTION. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10353103 ↗
• InjuryJul 23, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION. IT IS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 10316469 ↗
• InjuryMay 12, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION AFTER USING THE CATHETER AND DOCTOR ADVISED TO MAKE SURE THAT THE PATIENT CLEANED HERSELF BETTER. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10046516 ↗
• InjuryMay 5, 2020Improper Chemical Reaction; Difficult to Insert; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS DID NOT HAVE ENOUGH LUBRICATION AND THE PATIENT EXPERIENCED PAIN WITH INSERTION AND URETHRAL TEAR. THE PATIENT REPORTEDLY DEVELOPED A URINARY TRACT INFECTION AND WAS PRESCRIBED BACTRIM ANTIBIOTICS.

  Patient problems: Injury; Pain; Skin Tears; Urinary Tract Infection

  MAUDE report 10024095 ↗
• InjuryApr 2, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT SAID HER DOCTOR TOLD HER TO TAKE A BREAK FROM USING CATHETERS DUE TO GETTING UTIS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9917880 ↗
• MalfunctionMar 9, 2020Component Missing

  IT WAS REPORTED THAT THE SURE GRIP STATIONARY HANDLE WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9805785 ↗
• MalfunctionFeb 11, 2020Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PATIENT SAID SOME OF THE CATHETERS WERE BENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9694190 ↗
• MalfunctionDec 9, 2019Product Quality Problem; Product Quality Problem; Defective Device

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY CAUSING BLEEDING WITH USE. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 9437749 ↗
• MalfunctionNov 26, 2019Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID SOME OF THE CATHETERS WERE BENT AND UNCOMFORTABLE TO USE.

  Patient problems: Discomfort

  MAUDE report 9379435 ↗
• MalfunctionOct 29, 2019Device Damaged Prior to Use; Structural Problem; Defective Device; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS AN EXTRA PIECE OF PLASTIC AROUND THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9252099 ↗
• MalfunctionOct 29, 2019Material Deformation; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A CURVE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9252093 ↗
• MalfunctionOct 24, 2019Product Quality Problem; Tear, Rip or Hole in Device Packaging; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT ADVISED THAT THE CATHETERS WERE DRY. THE BOXES ALWAYS CAME IN BEAT UP, WHICH INCLUDED THE MOST RECENT ORDER.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9233340 ↗
• MalfunctionOct 3, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE MISSING FROM THE PACKAGING.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 9151069 ↗
• InjurySep 3, 2019Nonstandard Device; Material Integrity Problem; Nonstandard Device

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS TOO FLIMSY. THE CUSTOMER REPORTED THAT THE CATHETERS TOUCHED OTHER PARTS OF THE BODY BECAUSE THEY WERE TOO FLEXIBLE WHICH WAS NOT STERILE. THE PATIENT REPORTEDLY DEVELOPED A URINARY TRACT INFECTION AS A RESULT OF USING THE CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 8957725 ↗
• InjuryJul 30, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SINCE THE PATIENT SWITCHED FROM USING 51914 CATHETERS TO 51614 CATHETERS SHE HAS BEEN EXPERIENCING FREQUENT URINARY TRACT INFECTIONS. THE URINARY TRACT INFECTIONS WAS REPORTEDLY TREATED WITH PRESCRIBED CEPHALEXIN 500MG ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8842741 ↗
• MalfunctionJul 30, 2019Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS NOT MOIST.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8842158 ↗