Magic3™ Intermittent Catheter 53616Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00801741068584), received between May 8, 2017 and Feb 4, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (10 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2026Component Misassembled

  IT WAS REPORTED THAT THE PATIENT CALLED SPOKE WITH REPRESENTATIVE. IT WAS DISCOVERED THAT ONE OF THE BOXES OF 30 CATHS DON'T HAVE THE SURE GRIP ON IT AND THE PATIENT RECEIVED THE WRONG TYPES OF CATHS 53616. PUT IN A PU/EX TO SEND OUT A REPLACEMENT RH53616G. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264494 ↗
• MalfunctionJan 6, 2026Incorrect Measurement

  IT WAS REPORTED THAT CUSTOMER CALLED ON BEHALF OF THEIR CLIENT AND ADVISED THAT THE CUSTOMER REPORTED TO THEM THAT THEY HAD EXPERIENCED ISSUES WITH THE INTERMITTENT CATHETER 53616, THEY USED TO RECEIVE GREEN BOXES, HOWEVER SINCE THEY STARTED RECEIVING BLUE BOXES. THEY THOUGHT THERE WAS A MANUFACTURE DEFECT AS THAT CATHETERS IN THE BLUE BOXES ARE CAUSED PAIN DURING INSERTION AS THEY CATHETERIZED THEMSELF, AND THOUGHT THEY WERE TOO BIG, CAUSED SO MUCH PAIN AND LITTLE LUBRICANT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 23984932 ↗
• MalfunctionApr 23, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT PATIENT SAID THE LAST ORDER DID NOT HAVE THE ADHESIVE TO STICK TO WALL. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21892337 ↗
• MalfunctionApr 11, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THERE WAS A CATHETER THAT HAD AN EXTREMELY ROUGH EDGE, AND IF THEY WOULD HAVE USED IT, THE ITEM WOULD HAVE TORE UP HER URETHRA. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21824707 ↗
• MalfunctionFeb 12, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO COLLAR ON THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER SO IT MADE IT HARD TO HOLD BECAUSE IT WAS SO SLIPPERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363686 ↗
• MalfunctionJun 7, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT INTERMITTENT CATHETER CAME WITHOUT THE SLEEVE. NO PATIENT INJURY WAS REPORTED. (LOT #JUHY9187, LOT #JUHT0341, LOT #JUHV0990).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19483522 ↗
• MalfunctionJun 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT INTERMITTENT CATHETER CAME WITHOUT THE SLEEVE. NO PATIENT INJURY WAS REPORTED. (LOT #JUHY9187, LOT #JUHT0341, LOT #JUHV0990).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476059 ↗
• MalfunctionJun 6, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT INTERMITTENT CATHETER CAME WITHOUT THE SLEEVE. NO PATIENT INJURY WAS REPORTED. (LOT #JUHY9187, LOT #JUHT0341, LOT #JUHV0990).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19476056 ↗
• MalfunctionJun 5, 2024Complete Blockage; Device Handling Problem; Complete Blockage; Device Handling Problem

  IT WAS REPORTED THAT THE PATIENT REPORTED BLEEDING AND THAT THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER WAS CLOGGED WITH ONE DROP OF BLOOD. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19473275 ↗
• MalfunctionJun 5, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS MISSING INSERTION SLEEVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467035 ↗
• MalfunctionMay 29, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE MISSING INSERTION SLEEVES. THE REPRESENTATIVE INFORMED THE THEY WOULD PICK UP AND SHIP MORE. THE AFFECTED LOTS ARE LOT# 1- JUHY9187 , LOT#2- JUHV0990 , LOT# 3- JUHT0341.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19417011 ↗
• MalfunctionMay 29, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE MISSING INSERTION SLEEVES. THE REPRESENTATIVE INFORMED THE THEY WOULD PICK UP AND SHIP MORE. THE AFFECTED LOTS ARE LOT# 1- JUHY9187 , LOT#2- JUHV0990 , LOT# 3- JUHT0341.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19417008 ↗
• MalfunctionMay 29, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE MISSING INSERTION SLEEVES. THE REPRESENTATIVE INFORMED THAT THEY WOULD PICK UP AND SHIP MORE. THE AFFECTED LOTS ARE LOT# 1- JUHY9187, LOT# 2- JUHV0990, LOT# 3- JUHT0341.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414984 ↗
• MalfunctionSep 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT RECEIVED MAGIC 3 MALE INTERMITTENT CATHETER FROM THESE TWO LOTS WERE MISSING THE GRIPPER. THE PATIENT REPORTED ISSUES WITH LOT#JUGU0788, LOT# JUHP0797. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 06SEP2023, IT WAS REPORTED THAT THE PATIENT RECEIVED MAGIC 3 MALE INTERMITTENT CATHETER WERE MISSING THE GRIPPER. THE PATIENT REPORTED ISSUES WITH LOT#JUGU0786.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825525 ↗
• MalfunctionApr 13, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC3 GO MALE INTERMITTENT CATHETERS DID NOT HAVE MUCH LUBE. CUSTOMER ASKED IF THE CATHETER WOULD DRY OUT AND HOW LONG IT WOULD BE GOOD. REPRESENTATIVE ADVISED CUSTOMER ON USAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732634 ↗
• MalfunctionMar 17, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT THE PATIENT OPENED ABOUT SIX INTERNMENT CATHETERS, AND THEY DID NOT HAVE LUBRICANT IN THE PACKETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565223 ↗
• MalfunctionFeb 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS HAVING A DIFFICULT TIME GETTING THEM IN. THE PATIENT WANTED TO TRY DIFFERENT MAGIC 3 GO MALE INTERMITTENT CATHETER AS REALLY WANTED AND THEY WERE BO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363742 ↗
• MalfunctionOct 26, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE STICKY AND NOT LUBRICATED ENOUGH COMPARED TO PRIOR ORDER OF CATHETERS. PER FOLLOW UP VIA PHONE ON 19-OCT-2022, CUSTOMER STATED THAT THERE WAS NOT ENOUGH LUBRICANT AND ALSO STATED THAT CUSTOMER WAS ABLE TO USE THE PRODUCT WITH EXTRA LUBRICANT ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15675087 ↗
• MalfunctionSep 22, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH LUBRICANT FOR THE MAGIC3 GO MALE INTERMITTENT CATHETER IN THE BURST PACK. THE REPRESENTATIVE PROVIDES THE DIRECTION TO THE CUSTOMER TO MAKE SURE THE CATHETER GOT ALL LUBRICATION FROM THE BURST PACK, AND THE PATIENT REFUSED THAT. THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS. PER FOLLOW UP VIA PHONE 05JAN2022, IT WAS REPORTED THAT THE CUSTOMER HAD NOT SEEN SAME ISSUE SINCE, EVERYTHING HAD BEEN FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12513284 ↗
• MalfunctionSep 3, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THERE WAS NO LUBRICANT IN THE MAGIC3 GO MALE INTERMITTENT CATHETER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12424970 ↗
• MalfunctionJun 29, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE 9 UNITS OF INTERMITTENT CATHETER HAD BUBBLE WITH RELIEF. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086413 ↗
• MalfunctionJun 29, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 19 UNITS OF MAGIC 3 CATHETERS WERE CONTAMINATED. IT WAS NOTED THAT THERE WAS NO IMPACT TO THE PATIENT AND THE PRODUCT WAS NOT AVAILABLE FOR SALE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12085882 ↗
• MalfunctionFeb 9, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETER WHICH WERE DIFFICULT TO INSERT DUE TO NO LUBRICATION ON THEM AND NOT LUBRICATED WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11302298 ↗
• MalfunctionDec 29, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT CANNOT USE BARD CATHETERS WHICH WERE DIFFICULT TO INSERT AND STATED THAT THEY HAD TO GO TO THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11087713 ↗
• MalfunctionMay 18, 2020Improper Chemical Reaction; Difficult to Insert; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS ARE NOT LUBRICATED ENOUGH AND CAUSED BLEEDING. THE PATIENT WENT TO THE EMERGENCY ROOM. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 10066140 ↗