Magic3 Go™ Intermittent Urinary Catheter 51816Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741098086), received between Dec 10, 2018 and Jun 17, 2025 — classified as 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Biocompatibility” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Apr 20, 2023Class IIOpen, Classified

   Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

   Z-1698-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING IRRITATION, WHICH THEY WENT TO DOCTOR OFFICE BUT THEN THE ISSUE WAS HAPPENING AGAIN WHERE THE SKIN WAS GETTING VERY WARM. RECOMMENDED TO CONTACT HEALTHCARE PROFESSIONAL TO DISCUSS ISSUE AND CALL BACK ABOUT INTERMITTENT CATHETERS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Skin Inflammation/ Irritation

  MAUDE report 22229271 ↗
• MalfunctionNov 13, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WERE NORMALLY 4 IDENTICAL EYELETS IN INTERMITTENT CATHETER, BUT HERE IT HAD 2 SMALL ONES AND 2 NORMAL ONES. IT WAS FOUND BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675832 ↗
• InjurySep 1, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE CARDINAL HEALTH AT HOME HAD ISSUED A VOLUNTARY URGENT MEDICAL DEVICE RECALL ON THE ITEMS AND LOT NUMBERS. THE RECALL WAS DUE TO A BD MANUFACTURING SITE PRODUCING MAGIC3 GO INTERMITTENT SILICONE CATHETER OBSERVED A NON CONFORMING CONDITION WHERE SOME CATHETERS MANUFACTURED HAD THE CLEAR RESEALING LABEL SEPARATING FROM THE PRODUCT FOIL POUCH, RESULTING IN A POSSIBLE PATH INTO THE PRODUCT PACKAGING THAT COULD POTENTIALLY RESULT IN A STERILE BREACH IF THE SEPARATION REACHED THE OPENING IN THE FOIL PACKAGE. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, NO LONGER HAD INFECTION AFTER RECEIVED SHOTS OF A STRONG ANTIBIOTIC AND THE DOCTOR ADVISED THE PATIENT TO STOP USING THE CATHETER. THE MAGIC3 GO INTERMITTENT THE PATIENT WAS USING WAS PART OF THE RECALLED CATHETERS.

  Patient problems: Unspecified Infection

  MAUDE report 17672757 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DID NOT SPECIFY THE TIMEFRAME OF THE URINARY TRACK INFECTION. THE PATIENT HAS SEVERAL URINARY TRACK INFECTION. THE RMA DONE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17051333 ↗
• InjuryDec 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AT LEAST 2 URINARY TRACT INFECTION FROM USING THE MAGIC 3 GO INTERMITTENT CATHETER WITHIN THE PAST YEAR. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN. PER FOLLOW UP VIA PHONE ON 23-DEC-2022, IT WAS REPORTED THAT THE PATIENT WAS PRESCRIBED WITH ANTIBIOTICS BY THE DOCTOR FOR URINARY TRACT INFECTION AND STATED THAT THE PATIENT WAS STILL USING MAGIC 3 GO CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 16077074 ↗
• MalfunctionJun 21, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER ALWAYS ORDERS THE MAGIC 3 GO WITH 16-INCH TUBES, BUT THEY RECEIVED A BOX THAT LOOKED LIKE TUBES THAT ARE ONLY ABOUT 4 INCHES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14752979 ↗
• MalfunctionMar 23, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO INTERMITTENT CATHETERS DRIED OUT QUICKLY WHILE USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13860053 ↗
• InjuryMar 14, 2022Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MAGIC 3 GO INTERMITTENT CATHETER CAUSED INFECTIONS AND NOT USING AT THE MOMENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 13757562 ↗
• MalfunctionOct 21, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE MAGIC 3 INTERMITTENT CATHETER BECAME CLOGGED AND THE PATIENT HAD TO IRRIGATE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673935 ↗
• MalfunctionOct 13, 2021Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH TEN OF THE MAGIC 3 INTERMITTENT CATHETERS AS THEY WERE NOT DRAINING. PATIENT STATED THAT THEY LIKED THOSE CATHETERS, IT WAS JUST SOME OF THEM WOULD NOT DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624596 ↗
• MalfunctionFeb 26, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE 6 OF THE MAGIC 3 GO INTERMITTENT CATHETERS JUST HAD THE FUNNEL AND THERE WAS NO CATHETER.

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

  MAUDE report 11387962 ↗
• MalfunctionFeb 12, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE MAGIC 3 GO INTERMITTENT CATHETERS HAD A BARB AND IT SCRAPPED THE PATIENTS URETHRA SO BADLY. THE PATIENT HAD TO USE A FOLEY FOR 2 WEEKS SO THAT IT COULD HEAL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 11321887 ↗
• MalfunctionDec 30, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ONE OF THE PACKAGES ONLY HAD A FUNNEL IN IT AND THE INTERMITTENT CATHETER WAS MISSING.

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

  MAUDE report 11098372 ↗
• MalfunctionNov 2, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT TRIED USING ONE OF THE CATHETERS BUT COULDN¿T GET ANY URINE OUT AND HAD TO GO TO THE EMERGENCY ROOM (ER), WHERE THEY PUT IN A FOLEY UNTIL PATIENT CAN MEET DOCTOR. IT WAS NOTED THAT HISTORICALLY PROVIDED THIS PATIENT WITH BOTH THE 51816 AND A CATHETER FROM ANOTHER MANUFACTURER HOWEVER, PATIENT WAS NOT SPECIFIC ABOUT WHICH CATHETER AND WAS SPEAKING ABOUT IN THIS COMPLAINT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10773971 ↗
• InjurySep 15, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS GETTING URINARY TRACT INFECTION FROM THE CATHETERS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 10536422 ↗
• InjuryAug 7, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD GOT AN INFECTION AND HAD TO TAKE MEDICATION AND WAS NO LONGER USING CATHETERS. ALSO PATIENT THOUGHT THE CATHETERS CAUSED THE INFECTION..

  Patient problems: Unspecified Infection

  MAUDE report 10382753 ↗
• InjuryJul 28, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION BUT WAS NOT SURE. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 10333802 ↗
• MalfunctionJul 28, 2020Improper Chemical Reaction; Material Integrity Problem; Improper Chemical Reaction

  IT WAS REPORTED THAT THE SOME OF THE CATHETERS WERE NOT VERY LUBRICATED.

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

  MAUDE report 10333631 ↗
• InjuryJul 23, 2020Patient-Device Incompatibility; Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT GOT URINARY TRACK INFECTION BY USING CATHETER WHICH RESULTED IN IRRITATION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED

  Patient problems: Irritation; Urinary Tract Infection

  MAUDE report 10316513 ↗
• MalfunctionMay 27, 2020Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE FRENCH SIZE WAS TOO BIG AND IT CAUSED THE PATIENT TO BLEED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 10093223 ↗
• InjuryApr 20, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT WHILE USING THE CATHETER, THE PATIENT HAD A URINARY TRACT INFECTION AND IT CAUSED A BURNING SENSATION.

  Patient problems: Burning Sensation; Urinary Tract Infection

  MAUDE report 9977312 ↗
• InjuryFeb 13, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE UTIS SINCE SHE STARTED USING THE CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9706809 ↗
• InjuryOct 8, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED 3 URINARY TRACT INFECTIONS WHILE USING THE MAGIC 3 CATHETER.

  Patient problems: Urinary Tract Infection

  MAUDE report 9168179 ↗
• MalfunctionMay 16, 2019Misassembled; Material Deformation; No Flow; Misassembled

  IT WAS REPORTED THAT UPON REMOVAL OF THE MAGIC 3 CATHETER, THE PATIENT NOTICED THAT THE CATHETER WAS MISSING OPEN EYELETS. THE PATIENT WAS UNABLE TO VOID WITH THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8615830 ↗
• InjuryJan 31, 2019Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED SEVERAL URINARY TRACT INFECTIONS AFTER USE OF THE MAGIC 3 CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8294531 ↗