Magic3™ Intermittent Catheter 53614Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00801741068577), received between May 17, 2017 and Feb 3, 2026 — classified as 11 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (15 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Component Misassembled

  IT WAS REPORTED THAT THE PATIENT HAD COME ACROSS SOME OF THEIR CATHETERS WITHOUT EYELETS. THEY HAVE ALREADY CREDITED OR REPLACED PRODUCT FOR OUR CUSTOMER AND ALSO ASKED HAVE CREDIT APPLIED TO CARDINAL HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24254573 ↗
• MalfunctionDec 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT 3 INDIVIDUAL CATHETER SLEEVES WERE MISSING THE CATHETER. USED WITH FEMALE WICKS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 10DEC2025, IT WAS REPORTED THAT HE RECEIVED SLEEVES THAT WERE MISSING CATHETERS AND HE DISCARDED THE EMPTY SLEEVES. ON THE MOST RECENT BATCH OF CATHETERS THAT HE RECEIVED, THREE OF THE CATHETERS WERE BENT WHEN HE OPENED THE BOX. IT APPEARED THAT THE CATHETERS WERE JAMMED INTO THE BOX DURING PACKAGING. CUSTOMER DISCARDED THOSE AS WELL. NO SAMPLES ARE AVAILABLE. NO LOT NUMBERS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831709 ↗
• MalfunctionOct 27, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THAT 2/3 CAME UNUSABLE, BENT, PACKAGED TOO TIGHTLY, LED TO BENDING. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA PHONE ON 10DEC2025, IT WAS REPORTED THAT HE RECEIVED SLEEVES THAT WERE MISSING CATHETERS, AND HE DISCARDED THE EMPTY SLEEVES. ON THE MOST RECENT BATCH OF CATHETERS THAT HE RECEIVED, THREE OF THE CATHETERS WERE BENT WHEN HE OPENED THE BOX. IT APPEARED THAT THE CATHETERS WERE JAMMED INTO THE BOX DURING PACKAGING. CUSTOMER DISCARDED THOSE AS WELL. NO LOT NUMBERS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393611 ↗
• MalfunctionSep 4, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT SAID THE TIP WAS SHARP AND ANGULAR AND ALSO SAID IT SEEMED SMALLER THAN THE OTHER CATHETERS HE USES. PATIENT SAID FRENCH SIZE WAS CORRECT BUT STILL SEEMED SMALLER. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965842 ↗
• MalfunctionAug 28, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THE TIP WAS SHARP AND ANGULAR AND HE SAID IT SEEMED SMALLER THAN THE OTHER CATHETERS HE USES. HE SAID FRENCH SIZE WAS CORRECT BUT STILL SEEMED SMALLER. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22912898 ↗
• MalfunctionJun 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT STATED THE BOXES HE RECEIVED WERE ALL MISSING THE GREEN SLEEVE NEEDED FOR GRIPPING THE CATHETER. THE PATIENT HAS USED 10 SO FAR AND EACH ONE WERE MISSING THE GREEN FUNNEL PART THAT HE STATES HE NEEDS. EXPLAINED THAT THIS IS A DIFFERENT ITEM AND APOLOGIZED AGAIN. CHANGED SO TEMPLATE FOR FUTURE ORDERS AND SENT REPLACEMENT. PU CREATED TO RETURN REMAINING SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22134010 ↗
• MalfunctionSep 20, 2024Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT 2 OUT OF ONE BOX MAGIC 3 HYDROPHILIC INTERMITTENT CATHETERS WERE NOT DRAINING THE URINE. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 17OCT2024, STATED THAT TWO CATHETERS OUT OF TWO DIFFERENT BOXES DID NOT ABSORB THE URINE. THE CUSTOMER STATED THAT THEY DID NOT EXAMINE THE CATHETERS BUT THREW THEM AWAY AND RECEIVED TWO REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266657 ↗
• MalfunctionApr 12, 2023Device Damaged Prior to Receipt by User; Component Misassembled; Device Damaged Prior to Receipt by User; Component Misassembled

  IT WAS REPORTED THAT THE CUSTOMER ORDERED THROUGH LIBERATOR AND RECEIVED A TOTAL OF (B)(4) BOXES OF INTERMITTENT CATHETER DID NOT HAVE SHIPPING SHEET WITH THE ORDER NUMBER. ALSO STATED THAT FOR (B)(4) BOXES RECEIVED, NONE OF THE CATHETERS HAD SLEEVES ON THEM AND THEY WOULD NEED REPLACEMENTS. PER FOLLOW UP VIA PHONE ON 02APRIL2023, IT WAS REPORTED THAT CUSTOMER UNDERSTANDS THAT THEY WERE SENT A SUBSTITUTE CATHETER BECAUSE THE ONES THEY NORMALLY USED WERE ON BACKORDER WITHOUT A RELEASE DATE. THEY ALSO STATED THAT ITEM # (B)(4) LOT # JUGV1681 HAD NO HOLES IN THE TIP, AND THEY HAD SAMPLES OF THAT ONE AVAILABLE .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16725410 ↗
• MalfunctionAug 24, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC3 HYDROPHILIC INTERMITTENT CATHETER WAS NOT LUBRICATING UP RIGHT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12359344 ↗
• InjuryFeb 23, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE MAGIC 3 HYDROPHILIC INTERMITTENT CATHETERS HAD CAUSED THE PATIENT TO GOT INFECTIONS. PATENT HAD 3 IN A ROW. REPRESENTATIVE ADVISED PATIENT THAT TO CONSULT THE HEALTH CARE PROFESSIONAL IF PATIENT WAS DECREASING USAGE ON OWN AND ADVISED THAT A COURTESY ORDER COULD BE REQUESTED IF NEED BE TO HOLD THE PATIENT OVER UNTIL THE ACTUAL ORDER SHIPS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 11366659 ↗
• MalfunctionNov 19, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT HAD ONE MAGIC 3 GO MALE INTERMITTENT CATHETER THAT HAD NO EYELETS (HOLES) IN IT.

  Patient problems: No Patient Involvement

  MAUDE report 10868230 ↗
• MalfunctionJul 17, 2020Defective Component; Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT HALF OF THE CATHETERS IN THE ORDER WERE NOT LUBRICATED AT ALL AND SEEMS TO BE DEFECTIVE.

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

  MAUDE report 10289192 ↗
• MalfunctionMay 6, 2020Product Quality Problem; Difficult to Insert; Product Quality Problem; Component Missing

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY, WHICH MADE THEM DIFFICULT TO INSERT. IT IS UNKNOWN IF THE CUSTOMER WAS ABLE TO FULLY INSERT AND VOID. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10028531 ↗
• MalfunctionApr 22, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT SAID SOME OF THE CATHETERS WERE DIFFICULT TO INSERT ¿ ABOUT 10 OR MORE IN EACH OF THE LAST TWO OR THREE BOXES ¿ AND HAD TO BE DISCARDED. IT IS UNKNOWN IF THE PATIENT WAS ABLE TO VOID.

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

  MAUDE report 9986376 ↗
• MalfunctionApr 8, 2020Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER WAS HARD TO INSERT. IT WAS UNKNOWN IF THE PATIENT WAS ABLE TO VOID.

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

  MAUDE report 9934753 ↗
• MalfunctionMar 9, 2020Component Missing

  IT WAS REPORTED THAT THE LUBRICANT WAS MISSING FROM SOME OF THE CATHETERS.

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

  MAUDE report 9805898 ↗
• MalfunctionFeb 25, 2020Difficult to Insert; Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE CATHETERS WERE SHARP AND LACKED LUBRICITY, WHICH CAUSED SELF LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9750881 ↗
• MalfunctionFeb 25, 2020Product Quality Problem; Sharp Edges; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE SHARP AND LACKED LUBRICITY, WHICH CAUSED SELF LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 9750779 ↗
• MalfunctionFeb 25, 2020Difficult to Insert; Product Quality Problem; Temperature Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER LACKED LUBRICITY. THE PATIENT STATED THAT THE DURING THE LUBRICATION PROCESS, THE CATHETER DID NOT GET " SLIMY" OR "STICKY" AND WAS PAINFUL TO INSERT. THE PATIENT EXPRESSED CONCERNS ABOUT THE PACKAGE BEING DELIVERED IN -20 BELOW WEATHER, AND LEFT ON HIS PORCH FOR HOURS.

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

  MAUDE report 9750565 ↗
• MalfunctionJan 6, 2020Difficult to Insert; Short Fill; Short Fill

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH WATER IN THE BURST PACKET TO PROPERLY LUBRICATE THE CATHETER. THE PATIENT REPORTEDLY EXPERIENCED PAIN DURING INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9552598 ↗
• InjuryOct 15, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UTI WITH USE. MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 9192319 ↗
• MalfunctionSep 9, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS TWISTED INSIDE OF THE PACKAGING.

  Patient problems: No Patient Involvement

  MAUDE report 8977246 ↗
• MalfunctionAug 2, 2019Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER WALLS WERE THICKER THAN USUAL WHICH ALLEGEDLY MADE THE CATHETER LESS FLEXIBLE.

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

  MAUDE report 8857892 ↗
• MalfunctionJul 18, 2019Misassembled; Misassembled; Insufficient Flow or Under Infusion; Defective Component

  IT WAS REPORTED THAT THE EYELETS ON THE MAGIC 3 CATHETER WERE SMALLER THAN USUAL WHICH ALLEGEDLY MADE THE URINE FLOW SLOWER.

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

  MAUDE report 8804628 ↗
• MalfunctionJun 10, 2019Difficult to Insert

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WOULD ONLY GO IN ABOUT 3 OR 4 INCHES AND WOULD NOT GO IN ANY FURTHER. THE PATIENT WAS REPORTEDLY UNABLE TO VOID USING THE CATHETER AND IT HAD TO BE REMOVED AND REPLACED.

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

  MAUDE report 8682821 ↗