Magic3™ Intermittent Catheter 51610Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741068225), received between Sep 10, 2018 and Jan 7, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT BEFORE USE, THE HYDROPHILIC SURFACE OF THE INTERMITTENT CATHETER WAS UNEVEN AND SOME PARTS OF THE CATHETER APPEARED DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092756 ↗
• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD UNEVEN COATING ON THE CATHETER SURFACE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092494 ↗
• InjuryMar 21, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE SENT WITHOUT POLISHED EYELIDS AND IT WAS CAUSING THE PATIENT TO GET URINARY TRACT INFECTION AND POSSIBLE STAPH INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION AND STAPH INFECTION.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 18948575 ↗
• MalfunctionMar 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT MANY OF THE MAGIC 3 HYDRO INTERMITTENT CATHETERS HAVE SPLIT OPEN AS THEY ARE USED AND IT CAUSED A MESS. PER LIBERATOR VIA PHONE ON 04MAR2024, IT WAS REPORTED THAT THE PATIENT DID NOT LIKE MAGIC 3 HYDRO INTERMITTENT CATHETERS AND HAD SPLITS. PATIENT EXPERIENCED PAINFUL AND HAD A HARD TIME WITH THESE AND COULD NOT USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 18932095 ↗
• MalfunctionDec 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT PATIENT HAD DIFFICULTY UPON WITHDRAWAL, FELT VERY SCRATCHY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 18400255 ↗
• MalfunctionAug 15, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT SOME OF THE MAGIC3 HYDRO INTERMITTENT CATHETERS DID HAVE THE LUBRICANT AND THERE WERE SOME MISSING THE CATHETER IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15224935 ↗
• MalfunctionAug 11, 2022Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT SOME OF THE MAGIC3 HYDRO INTERMITTENT CATHETERS DID HAVE THE LUBRICANT AND THERE WERE SOME MISSING THE CATHETER IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15208372 ↗
• MalfunctionNov 16, 2021Improper Chemical Reaction; Patient Device Interaction Problem; Improper Chemical Reaction; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE HARD TO OPEN AND THE PATIENT HAD TO USE SCISSORS. THE PATIENT ALSO SAID THAT THE LUBRICATION WAS CAUSING IRRITATION, A BURNING SENSATION AND REDNESS ON THE URETHRAL OPENING. PER EMAIL FROM CARDINAL HEALTH ON (B)(6) 2021, IT WAS STATED THAT THE PACKAGING OF INTERMITTENT CATHETER WAS DIFFICULTY TO OPEN AND WERE CAUSING IRRITATION, BURNING AND REDNESS ON THE URETHRAL OPENING AND LABIA. ALSO STATED THAT THE PATIENT WOULD BE SCHEDULING AN APPOINTMENT WITH THE DOCTOR.

  Patient problems: Burning Sensation; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 12823631 ↗
• InjuryJan 14, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS THE INCORRECT WIDTH. THE PATIENT EXPERIENCED IRRITATION WHILE REMOVING THE CATHETER AND DEVELOPED A UTI. THE PATIENT WAS TREATED BY THEIR PHYSICIAN WITH UNKNOWN MEDICATIONS.

  Patient problems: Irritation; Urinary Tract Infection

  MAUDE report 8245726 ↗
• MalfunctionSep 10, 2018Difficult to Insert; Product Quality Problem; Retraction Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE NOT SMOOTH AND WERE GETTING STUCK DURING INSERTION AND REMOVAL. THERE WAS SOME SELF LIMITED PAIN.

  Patient problems: No Consequences Or Impact To Patient; Pain

  MAUDE report 7861612 ↗