Magic3™ Intermittent Catheter 53618Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741068591), received between Nov 18, 2018 and Apr 2, 2025 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Improper Chemical Reaction; Component Misassembled; Improper Chemical Reaction; Component Misassembled

  IT WAS REPORTED THAT AUTHORIZATION STATED ONE OF THE CATHETERS CAME WITHOUT LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21751529 ↗
• MalfunctionNov 11, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER WAS EXTREMELY UPSET AND STATED THAT WHEN THEY OPENED A BOX OF INTERMITTENT CATHETERS AND THEY DID NOT HAVE THE SURE GRIP ON THEM, STATED THAT ALL 15 BOXES HAD THE SAME LOT #: JUJN9129. REPRESENTATIVE ADVISED TO HOLD ONTO PACKAGE AND INFORMED A REPRESENTATIVE SHOULD BE CALLING TO GET PREVIOUS ORDER PICKED UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651197 ↗
• InjuryOct 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DOCTOR TOLD CUSTOMER TO STOP IRRIGATE THE INTERMITTENT CATHETER ON PATIENT BECAUSE DOCTOR SAID IT WAS CAUSING URINARY TRACT INFECTIONS (UTIS).

  Patient problems: Urinary Tract Infection

  MAUDE report 20472555 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE CATHETERS ARE CAUSING URINARY TRACT INFECTION TO THE PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17260405 ↗
• MalfunctionJun 26, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT STATED THERE WAS HARDLY ANY LUBRICANT, IT WAS HARDLY THERE AT ALL AND THE CATHETER WAS ACTUALLY SQUEAKING. PATIENT WANTED SOMETHING DIFFERENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198914 ↗
• MalfunctionJan 3, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT MALE INTERMITTENT CATHETER CUT THE PATIENT AND MADE BLEED. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON 22DEC2022, IT WAS STATED THAT THE ISSUE HAD BEEN RESOLVED AND THE BLEEDING RESOLVED ON ITS OWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16087541 ↗
• MalfunctionDec 29, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THESE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETERS WERE NOT LUBRICATED AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA PHONE ON (B)(6) 2022, IT WAS STATED THAT THE ISSUE HAD BEEN RESOLVED AND THE BLEEDING RESOLVED ON ITS OWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16068376 ↗
• MalfunctionDec 19, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THESE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETERS WERE NOT SOFT AND PLIABLE, AND THE PATIENT WAS UNABLE TO GET THEM THROUGH THE PENIS. PATIENT FELT THESE ARE 3 YEARS OLD. AS PER ADDITIONAL INFORMATION ON 01DEC2022, PATIENT SAID THE INTERMITTENT CATHETER WAS TOO DRY TO USE, CAUSING ISSUES WITH INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16006246 ↗
• MalfunctionDec 19, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THESE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETERS WERE NOT SOFT AND PLIABLE, AND THE PATIENT WAS UNABLE TO GET THEM THROUGH THE PENIS. PATIENT FELT THESE ARE 3 YEARS OLD (BATCH# JUP9362). PER ADDITIONAL INFORMATION ON 01DEC2022, PATIENT SAID THE INTERMITTENT CATHETER WAS TOO DRY TO USE, CAUSING ISSUES WITH INSERTION (BATCH#JUGS0057) (BATCH# UNK).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16005383 ↗
• InjurySep 2, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEM WITH THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER AND PREFERRED TO USE MAGIC 3 GO CATHETERS. THOSE CATHETERS WERE NOT PRE LUBRICATED HENCE IT WAS HARD TO INSERT. PATIENT GOT AN INFECTION AND HAD TO GO TO THE HOSPITAL. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12414466 ↗
• MalfunctionAug 11, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE LUBRICANT OF INTERMITTENT CATHETERS WAS NOT AS SMOOTH WHEN INSERTING AS WITH RECENT ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307123 ↗
• MalfunctionFeb 11, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT NO LIQUID CAME OUT OF THE SILVER POUCH TO ACTIVATE THE COATING WHEN THE PATIENT CRUSHED THE SILVER POUCH BEFORE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11317747 ↗
• MalfunctionNov 20, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE EYELETS ON THE MAGIC 3 INTERMITTENT CATHETER, MALE WERE NOT SMOOTH AND ALLEGEDLY CAUSED THE PATIENT IRRITATION. THE PATIENT WAS UNABLE TO CONTINUE USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Irritation; Patient Problem/Medical Problem

  MAUDE report 8088734 ↗
• MalfunctionNov 18, 2018Device Damaged Prior to Use; Device Damaged Prior to Use; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED IRRITATION WHILE USING THE MAGIC 3 CATHETER, DUE TO THE EYELETS NOT BEING SMOOTH.

  Patient problems: Irritation

  MAUDE report 8083002 ↗