Magic3™ Intermittent Catheter 53314Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00801741068423), received between Jun 28, 2018 and Sep 9, 2026 — classified as 3 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Component Missing” (5 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Inaccurate Flow Rate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50700904 ↗
• MalfunctionSep 12, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT "WHEN WE TAKE AN INDWELLING URINARY CATHETER (IUC) OUT AND THE PATIENT WAS STILL RETAINING, WE ARE HAVING ISSUES WITH OUR 14FR I/O CAUSING URETHRAL IRRITATION, MICRO-TEARING, SLIGHTLY PINK TINGED URINE FROM TRAUMA, AND PATIENT COMPLAINTS OF FRICTION/PAIN. DUE TO THIS WE ARE HAVING TO REPLACE IUCS INSTEAD OF DOING I/O ON THE PATIENT MORE THAN 1-2 TIMES DUE TO PATIENT AND OR TEAM MEMBER COMPLAINTS. " NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hematuria; No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 23038004 ↗
• MalfunctionJul 30, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE 2 UNITS OF THE INTERMITTENT CATHETERS WERE FOUND TO HAVE RELIEF/RAISED BUBBLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253344 ↗
• MalfunctionMar 12, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 19 CONTAMINATED UNITS OF THE INTERMITTENT CATHETERS WERE FOUND TO HAVE DIRT .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11474504 ↗
• MalfunctionMar 9, 2021Incorrect Measurement; Material Too Soft/Flexible; Incorrect Measurement; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE 32 UNITS OF CATHETER HAD TOO THIN TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11447130 ↗
• MalfunctionDec 2, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SOMETIMES THE CUTS IN THE CATHETER WERE NOT CORRECT AND THE LIQUID WOULD NOT FLOW THROUGH THE CATHETER. IT WAS STATED THAT THERE WAS NO CUTS (EYELETS) IN THE CATHETERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10936215 ↗
• InjurySep 9, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE STRAIGHT CATHETERS DID NOT WORK ON PATIENT AND WANTS TO GO BACK TO COUDE. THE PRODUCT CATALOG NUMBERS INCLUDES ROC53314, ROC53614G, BAR4A5144. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 17AUG2020, THE PATIENT DEVELOPED A URINARY TRACT INFECTION DUE TO USE OF THE CATHETERS WHICH REPORTEDLY MADE THE CATHETERS DIFFICULT TO INSERT. THE INFECTION WAS TREATED WITH ANTIBIOTICS AND AFTER IT CLEARED UP, THE PATIENT WAS ABLE TO INSERT THE CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10511472 ↗
• MalfunctionAug 28, 2020Material Deformation; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SOME OF THE CATHETERS DID NOT HAVE EYELETS.

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

  MAUDE report 10468566 ↗
• InjuryMay 18, 2020Biocompatibility; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION, EVEN AFTER STOPPING USE OF THE ANTIBACTERIAL CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 10066543 ↗
• MalfunctionMar 17, 2020Device Damaged Prior to Use; Device Contamination with Chemical or Other Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS WERE ROUGH AND CAUSED PAIN AND SELF-LIMITED BLEEDING WHEN IT WAS INSERTED. THE PATIENT WAS ABLE TO FULLY INSERT THE CATHETER AND VOID.

  Patient problems: Blood Loss; Pain; Patient Problem/Medical Problem

  MAUDE report 9841509 ↗
• MalfunctionNov 13, 2019Component Missing; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PATIENT SAID THREE OF THE CATHETERS WERE MISSING FROM THE PACKAGING.

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

  MAUDE report 9314618 ↗
• MalfunctionOct 21, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THERE WAS NO LUBRICATION ON THE MAGIC 3 CATHETER. THE PATIENT REPORTEDLY HAD TO ADD HIS OWN LUBRICANT IN ORDER TO USE THE CATHETER.

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

  MAUDE report 9214800 ↗
• MalfunctionOct 16, 2019Component Missing; Manufacturing, Packaging or Shipping Problem; Component Missing

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BOX OF 30 MAGIC 3 INTERMITTENT MALE CATHETERS, AND 1 CATHETER SLEEVE WAS SEALED BUT WITHOUT A CATHETER.

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

  MAUDE report 9197037 ↗
• MalfunctionSep 26, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS ON THE CATHETER WERE SCRATCHING THE INSIDE OF THE PATIENT'S STOMA THAT CAUSED A LITTLE BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 9123062 ↗
• MalfunctionSep 26, 2019Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS ON THE CATHETER WERE SCRATCHING THE INSIDE OF THE PATIENT'S STOMA THAT CAUSED A LITTLE BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 9123059 ↗
• MalfunctionSep 26, 2019Device Damaged Prior to Use; Malposition of Device; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS ON THE CATHETER WERE SCRATCHING THE INSIDE OF THE PATIENT'S STOMA THAT CAUSED A LITTLE BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem; Tissue Damage

  MAUDE report 9122960 ↗
• MalfunctionSep 23, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE CATHETERS WERE MISSING EYELETS. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9104991 ↗
• InjurySep 13, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A URINARY TRACT INFECTION AFTER THE USE OF THE CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 9027359 ↗
• MalfunctionMay 30, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT A FEW OF THE INTERMITTENT CATHETERS DID NOT HAVE EYELETS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8655814 ↗
• MalfunctionMay 23, 2019Component Missing

  IT WAS REPORTED THAT THE PROTECTIVE SLEEVE WAS MISSING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8636184 ↗
• MalfunctionMar 4, 2019Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DID NOT HAVE ANY EYELETS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8387271 ↗
• MalfunctionFeb 13, 2019Device Damaged Prior to Use; Material Protrusion/Extrusion; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD AN EXTRUSION OF PLASTIC ON THE SIDE OF THE TIP BY THE ORIFICE, WHICH ALLEGEDLY INCREASED THE DIAMETER OF THE CATHETER.

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

  MAUDE report 8337382 ↗
• MalfunctionDec 5, 2018Misassembled; Misassembled; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DID NOT HAVE A DRAIN EYE PUNCHED.

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

  MAUDE report 8135369 ↗
• MalfunctionJun 28, 2018Device Inoperable; Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CATHETERS WERE NOT WORKING PROPERLY. FOLLOW UP ATTEMPTS HAVE BEEN MADE TO GATHER MORE DETAILED INFORMATION ABOUT THE MALFUNCTION; HOWEVER THIS IS THE EXTENT OF THE INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647541 ↗