Magic3™ Intermittent Catheter 51612Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00801741068232), received between Sep 26, 2017 and Mar 6, 2026 — classified as 6 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (7 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Incorrect Measurement

  IT WAS REPORTED THAT SOME CATHETERS WERE SHORTER IN LENGTH COMPARED TO OTHERS, DESPITE ORIGINATING FROM THE SAME BATCH. THIS DISCREPANCY WAS INITIALLY IDENTIFIED IN THE FIRST BATCH THAT WAS SENT TO A PATIENT AND, UNFORTUNATELY, IT WAS OBSERVED AGAIN IN THE REPLACEMENT BATCH THAT WAS SUBSEQUENTLY PROVIDED. THE PATIENT REPORTED THAT, IN SOME CASES, THE CATHETER DID NOT REACH THE BLADDER, RESULTING IN INADEQUATE URINE DRAINAGE. BATCH NUMBER(S): JUKQ0693 AND JUKR9153. IT WAS INFORMED ON 22JAN2026 REGARDING BATCH JUKR9153, AFTER WHICH (B)(4) UNITS WERE RETURNED TO US. THE MATERIALS REMAIN AT OUR FACILITIES. FOR THE OTHER BATCH THAT WE SENT AS A REPLACEMENT, THE PRODUCTS HAVE NOT YET BEEN RETURNED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535932 ↗
• MalfunctionMar 6, 2026Incorrect Measurement

  IT WAS REPORTED THAT SOME CATHETERS WERE SHORTER IN LENGTH COMPARED TO OTHERS, DESPITE ORIGINATING FROM THE SAME BATCH. THIS DISCREPANCY WAS INITIALLY IDENTIFIED IN THE FIRST BATCH THAT WAS SENT TO A PATIENT AND, UNFORTUNATELY, IT WAS OBSERVED AGAIN IN THE REPLACEMENT BATCH THAT WAS SUBSEQUENTLY PROVIDED. THE PATIENT REPORTED THAT, IN SOME CASES, THE CATHETER DID NOT REACH THE BLADDER, RESULTING IN INADEQUATE URINE DRAINAGE. BATCH NUMBERS JUKQ0693 AND JUKR9153. IT WAS INFORMED ON 22JAN2026 REGARDING BATCH JUKR9153, AFTER WHICH 56 UNITS WERE RETURNED TO US. THE MATERIALS REMAIN AT OUR FACILITIES. FOR THE OTHER BATCH THAT WE SENT AS A REPLACEMENT, THE PRODUCTS HAVE NOT YET BEEN RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533327 ↗
• InjurySep 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID THEY ARE GETTING UTI'S AND HAVING DIFFICULT TIME WITH THE CATHETERS. WENT OVER WASHING HANDS AND CLEANING AREA BEFORE CATHING, SENDING SAMPLES FOR PATIENT TO TRY OTHER CATHETERS BEFORE PLACING RO. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION PROVIDED FOR URINARY TRACT INFECTION. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23181730 ↗
• MalfunctionMay 23, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT NOT ENOUGH LUBRICITY ON SOME OF THE INTERMITTENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077931 ↗
• MalfunctionOct 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FEW INTERMITTENT CATHETERS WERE DEFORMED AND THEY HAD TO THROW THEM AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20505656 ↗
• MalfunctionJul 10, 2024Incorrect Measurement; Device Handling Problem; Incorrect Measurement; Device Handling Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER SYRINGE OPENING WAS TOO WIDE SPILLING OUT THE MEDICINE THAT THEY INSERTS INTO PATIENT BLADDER. THEY HAD 80 UNUSED AND 10 THAT THEY USED IN AN ATTEMPT TO MAKE THEM WORK. PER CLARIFICATION MAIL RECEIVED FROM LIBERATOR ON 09JUL2024, IT WAS REPORTED THAT PATIENT WAS HAVING ISSUES WITH THE CATHETERS WITH A USE BY DATE OF 28DEC. STATED THAT CUSTOMER NOT ONLY DRAIN OUT, BUT ALWAYS USED THE OPENING OF THE CATHETER TO INJECT MEDICINE. CUSTOMER SAID HOWEVER THE OPENING ON THIS ORDER THE OPENING ON THE CATHETER WAS BIGGER. CUSTOMER HAD 80 UNUSED AND 10 THAT THEY USED IN AN ATTEMPT TO MAKE THEM WORK. PER CUSTOMER ON 15JUL2024, THEY CONFIRMED ALL THE DETAILS OF THE REPORTED PRODUCT. CUSTOMER CONFIRMED PCN#51612, LOT JUJN9214, USE BY DATE 2028DEC. CUSTOMER STATED THAT THE ISSUE WAS THAT THE SYRINGE OPENING WAS TOO WIDE, WHICH MADE THE MEDICINE SPILL OUT WHILE TRYING TO ADMINISTER IT TO THE PATIENT. CUSTOMER RECOMMENDED A SMALLER OPENING FOR THE SYRINGE WOULD BE MORE USEFUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710733 ↗
• MalfunctionApr 3, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER LUBRICANT IN THE HYDRO WAS VERY WATERY AND HAD TO USE EXTRA LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031078 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION. PATIENT SAID DOCTOR PRESCRIBED MEDICATION BUT NOT ABLE TO DETERMINE THE ROOT CAUSE OF URINARY TRACT INFECTION. PATIENT SEEKING A RESUPPLY ORDER.

  Patient problems: Urinary Tract Infection

  MAUDE report 18836442 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 17031247 ↗
• MalfunctionApr 28, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT WORKING. CUSTOMER SAID WHEN USING THE URINE WENT EVERYWHERE AND NOT EASY TO LUBRICATE. REPRESENTATIVE OFFERED TO SEND A SAMPLE OF DIFFERENT STYLE CATHETERS AND PATIENT APPROVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831507 ↗
• MalfunctionApr 26, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT WORKING. CUSTOMER SAID WHEN USING THE URINE WENT EVERYWHERE AND NOT EASY TO LUBRICATE. REPRESENTATIVE OFFERED TO SEND A SAMPLE OF DIFFERENT STYLE CATHETERS AND PATIENT APPROVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16815078 ↗
• MalfunctionOct 12, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT KEPT RECEIVING SOME MAGIC 3 HYDROPHILIC INTERMITTENT CATHETERS CURVED AND BENT AND THE PATIENT THOUGHT IT WAS BECAUSE OF THE WAY THEY PACKAGED OR HANDLED BY THE CARRIER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15588234 ↗
• MalfunctionMar 18, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT PATIENT STATED THE LAST ORDER HAD TWO PACKAGES THAT HAD THE WATER PACKS INSIDE, BUT NO INTERMITTENT CATHETERS ARE IN THE PACKAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13814817 ↗
• MalfunctionDec 14, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER WAS VERY DIFFICULT TO USE AND THAT THE CATHETER NEEDED TO BE LUBRICATED BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003328 ↗
• MalfunctionDec 2, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT HAD A HARD TIME BY USING THE MAGIC 3 GO INTERMITTENT CATHETER AND EXPERIENCED IRRITATION DUE TO NOT BEING LUBRICATED ENOUGH. REPRESENTATIVE GAVE THE CATHETER PREPPING TIPS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12918831 ↗
• MalfunctionNov 9, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE MAGIC3 INTERMITTENT CATHETERS WERE DIFFICULT TO INSERT AND THE REPRESENTATIVE CHANGED THE TYPE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR LESS THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12781015 ↗
• MalfunctionOct 13, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT RECEIVED A BOX OF INTERMITTENT CATHETER SAMPLES FROM THE DOCTOR OFFICE AND THE BOX WAS CRUNCHED. PATIENT HAD TO THROW A COUPLE OF THE INTERMITTENT CATHETERS AWAY DUE TO THEM BEING BENT BADLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624570 ↗
• MalfunctionMar 11, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD AN ONGOING URINARY TRACT INFECTION. DOCTOR GAVE MEDICINES FOR IT. PATIENT WAS GOING TO SEE A NEW DOCTOR ON (B)(6) 2021. STATED THAT THE PATIENT HAD NOT USED MAGIC 3 HYDROPHILIC INTERMITTENT CATHETER THE WHOLE LIFE, BUT THEY HAD URINARY TRACT INFECTION THE WHOLE LIFE. AT THE LAST APPOINTMENT, THE DOCTOR MENTIONED IT MIGHT BE BECAUSE OF THE CATHETERS. THEY WENT TO THE HOSPITAL IN (B)(6) , THE INFECTION WENT FROM THE BLADDER TO KIDNEYS AND HAD BECOME SEPSIS. THE PATIENT DID NOT HAD SYMPTOMS LIKE OTHER PEOPLE, SO THEY DID NOT KNOW THAT THE PATIENT HAD A URINARY TRACT INFECTION.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 11468081 ↗
• MalfunctionFeb 24, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETERS WERE CONTAMINATED WITH A BLACK BUG LIKE SUBSTANCE IN THE LUBRICANT.

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

  MAUDE report 11373633 ↗
• MalfunctionFeb 1, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE WATER PACKET SHOULD BE PACKED ON THE PAPER SIDE, AND NOT THE PLASTIC FILM SIDE. ALSO, THE CUSTOMER FOUND THAT MOST OF THE CATHETERS WERE WRONGLY PACKED IN THE PREVIOUS SAMPLES. BOTH THE ROCHESTER AND BARD WERE INCONSISTENT IN THE ORIENTATION AND THE LAYERING OF THE WATER PACKET. WITH THE PACKET ADJACENT TO THE CLEAR PLASTIC FILM SIDE, FOLLOWED THE INSTRUCTIONS WOULD NOT RESULT IN ADEQUATE LUBRICATION OF THE CATHETER. ALSO, THE PACKET WAS OFTEN ALIGNED, SO THE WATER SQUIRTS TOWARD THE FUNNEL, BUT NOT AT THE TIP. THE NECK OF THE PLASTIC FILM IN THE ROCHESTER BRAND WAS TOO WIDE, ALLOWING THE PACKET TO SLIDE UP TOWARD THE FUNNEL. THE HYDROPHILIC VERSION, AVOIDS THE BUILD UP OF LUBRICANT WITH FREQUENT CATHETERIZATION. SOMETIMES, THE COATING SEEMS BARELY ADEQUATE. PER FOLLOW-UP VIA PHONE ON 12JAN2021, THE CUSTOMER ADDED THE WATER PACKET TO LUBRICATE THE CATHETER COMPLETELY BECAUSE OF THE WAY IT WAS POSITIONED IN THE PACKAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11263576 ↗
• MalfunctionJan 26, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE WATER PACKET SHOULD BE PACKED ON THE PAPER SIDE, AND NOT THE PLASTIC FILM SIDE. ALSO, THE CUSTOMER FOUND THAT SOME WERE THE RIGHT WAY, AND MOST WERE WRONGLY PACKED WITH THE PREVIOUS SAMPLES ALSO. BOTH THE ROCHESTER AND BARD WERE INCONSISTENT IN THE ORIENTATION AND THE LAYERING OF THE WATER PACKET. WITH THE PACKET ADJACENT TO THE CLEAR PLASTIC FILM SIDE, FOLLOWING THE INSTRUCTIONS DID NOT RESULT IN THE ADEQUATE LUBRICATION OF THE CATHETER. ALSO, THE PACKET WAS OFTEN ALIGNED, SO THE WATER SQUIRTED TOWARDS THE FUNNEL, NOT THE TIP. THE NECK OF THE PLASTIC FILM IN THE ROCHESTER BRAND WAS TOO WIDE, ALLOWED THE PACKET TO SLIDE UP TOWARDS THE FUNNEL. THE HYDROPHILIC VERSION, AVOIDED THE BUILDUP OF LUBRICANT WITH THE FREQUENT CATHETERIZATION. SOMETIMES, HOWEVER THE COATING SEEMED BARELY ADEQUATE. PER FOLLOW UP VIA PHONE ON (B)(6) 2021, THE CUSTOMER SOMETIMES ADDED THE WATER PACKET DID LUBRICATE THE CATHETER COMPLETELY BECAUSE OF THE WAY IT WAS POSITIONED IN THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 11229242 ↗
• MalfunctionDec 17, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO INTERMITTENT CATHETERS WERE NOT LUBRICATED ENOUGH TO INSERT. IT WAS STATED THAT THE PATIENT ENDED UP GOING TO THE EMERGENCY ROOM AND HAVING A FOLEY IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11030172 ↗
• MalfunctionSep 2, 2020Difficult to Insert; Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DIFFICULT TO INSERT AND CAUSED THE PAIN. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS LATER REPORTED FROM THE CUSTOMER VIA PHONE ON 02SEP2020, THE PATIENT HAD TO ADD THE ADDITIONAL LUBRICANT TO THE CATHETER AND WAS ABLE TO INSERT IT ALL THE WAY. THE PATIENT WAS ABLE TO VOID THE BLADDER IN SMALL AMOUNTS.

  Patient problems: Pain

  MAUDE report 10485574 ↗
• MalfunctionMay 4, 2020Material Twisted/Bent

  IT WAS REPORTED BY THE PATIENT THAT THE CATHETERS WERE BENT IN THE MIDDLE AND CAUSED PAIN. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Pain

  MAUDE report 10021173 ↗
• InjuryOct 10, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT SAID SHE EXPERIENCED PAIN DURING INSERTION. SHE ALSO SAID SHE RECEIVED A URINARY TRACT INFECTION. PER ADDITIONAL INFORMATION RECEIVED ON 27SEP2019, THE PATIENT RECEIVED ANTIOBIOTIC CIPRO.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 9175615 ↗