Magic3 Go Pediatric Catheter with SureGrip 52808GRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741136863), received between Sep 14, 2018 and Jul 27, 2023 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT'S ADAPTATION TO THE MAGIC 3 (HYDROPHILIC) WAS VERY BAD AND COMPLAINTS WERE RECEIVED ON ACTIVATION AND LUBRICATION OF THE CATHETER. AS PER THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023 STATED THAT IT WAS NOT A DEFECT OR ANY DEVIATION FROM THE QUALITY OF THE PRODUCTS. THE PURPOSE OF THE REPORT WAS TO INFORM THAT DUE TO THE POOR MANUAL DEXTERITY OF MOST USERS (WHEELCHAIR USERS WITH SPINAL CORD INJURIES ¿ PARAPLEGICS AND QUADRIPLEGICS), THEY ENCOUNTERED DIFFICULTIES IN ACTIVATING THE HYDROPHILIC MAGIC3 CATHETER, FAILING TO PERFORM THE PROCEDURE, IN REGARDS TO A LIMITATION DUE TO THE CHARACTERISTIC OF THE PRODUCT AND NOT ANY MANUFACTURING DEFECT. AS PER THE ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023, THE CUSTOMER PROVIDED THE REASONS FOR DIFFICULTIES WITH ACTIVATION IN DETAIL AS FOLLOWS: AS PREVIOUSLY REPORTED, MANY OF THE USERS WERE QUADRIPLEGIC, THAT IS, FOR SOME REASON THEY HAD A HIGH SPINAL CORD INJURY COMPROMISING TOTALLY OR PARTIALLY THE MOVEMENTS OF THE UPPER LIMBS. IN THE CASE OF TOTAL LOSS, THERE WAS A NEED FOR ANOTHER PERSON TO PERFORM THE PROCEDURE. HOWEVER, OTHERS MANAGE, ALBEIT WITH A LOT OF EFFORT, TO PERFORM THE TWEEZING MOVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404863 ↗
• MalfunctionSep 1, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE EYELET END OF THE MAGIC 3 GO INTERMITTENT CATHETER WAS SKINNY AND HAD A CURVE TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15342458 ↗
• MalfunctionSep 1, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE EYELET END OF THE MAGIC 3 GO INTERMITTENT CATHETER WAS SKINNY AND HAD A CURVE TO THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15335849 ↗
• MalfunctionAug 22, 2022Difficult to Insert; Sharp Edges; Difficult to Insert; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT COULD NOT USE INTERMITTENT CATHETER AND WHEN INSERTED THEY SCRAPED PATIENT. IT WAS STATED THAT THE INTERMITTENT CATHETER CAUSED A LOT OF BLEEDING AND PATIENT WAS USING 10 NOW. IT WAS STATED THAT THE DOCTOR WOULD SEND MEDICAL PRESCRIPTION. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 15265102 ↗
• InjuryAug 2, 2022Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS CAUSED THE PATIENT TO BLEED. PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON 19JUL2022, THE PATIENT WAS IN GOOD HEALTH AND FELT THE BLEEDING WAS CAUSED BY THE SIZE OF THE INTERMITTENT CATHETERS THAT WERE BEING USED. THE PATIENT WENT FROM USING A SIZE 8 DOWN TO A SIZE 5. THE SIZE 8 INTERMITTENT CATHETERS CAUSED THE PATIENT TO DEVELOP URINARY TRACT INFECTION (UTI) AND WAS PRESCRIBED AMOXICILLIN TO ALLEVIATE IT. ALSO USED SOAP AND WATER TO CLEAN THE AFFECTED AREA.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Urinary Tract Infection

  MAUDE report 15148640 ↗
• MalfunctionApr 26, 2022Difficult to Insert; Insufficient Device Problem Information; Difficult to Insert; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS HARD TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14208143 ↗
• MalfunctionDec 28, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT WRONG LABEL WAS ATTACHED ON THE MAGIC 3 INTERMITTENT CATHETER. PER FOLLOW UP VIA EMAIL ON 29NOV2021, CUSTOMER STATED THAT THEY COULD FIND CATHETERS OF DIFFERENT SIZE IN THE BOX. THE BIGGEST CATHETERS CAUSED THE PATIENT TO EXPERIENCE BURNING AND BLEEDING SENSATION DURING THE PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA EMAIL ON 01DEC021, THE COMPLAINANT WAS NOT SATISFIED WITH THE DIAMETER OF THE CATHETER, LEADING TO THE PATIENT EXPERIENCING BLEEDING AND BURNING FEELING, AND ASSUMED IT MUST BE A DIFFERENT FRENCH SIZE THAN WHAT IS ON THE LABEL, WHICH LED TO THE ALLEGATION OF THE LABELING BEING WRONG. THE USER FELT THAT THE LABELING MUST BE INCORRECT SINCE THE FRENCH SIZE WAS NOT WHAT THEY EXPECTED. PER FOLLOW UP VIA EMAIL ON 03JAN022, THE ISSUE OCCURRED IN 2 UNITS FROM SAME LOT NUMBER JUFR2087.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation

  MAUDE report 13093689 ↗
• MalfunctionDec 14, 2021Inadequate Instructions for Healthcare Professional; Illegible Information; Inadequate Instructions for Healthcare Professional; Illegible Information

  IT WAS REPORTED THAT WRONG LABEL WAS ATTACHED TO THE MAGIC 3 INTERMITTENT CATHETER. PER FOLLOW UP VIA EMAIL ON 29NOV2021 THE CUSTOMER STATED THAT THEY COULD FIND THE CATHETERS OF DIFFERENT SIZE IN THE BOX. THE BIGGEST CATHETERS CAUSED THE PATIENT TO EXPERIENCE BURNING AND BLEEDING SENSATION DURING THE PROCEDURE. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP VIA EMAIL ON 01DEC2021 THE COMPLAINANT WAS NOT SATISFIED WITH THE DIAMETER OF THE CATHETER WHICH LEADS TO THE PATIENT TO EXPERIENCE BLEEDING AND BURNING FEELING AND ASSUMED IT MUST BE A DIFFERENT FRENCH SIZE THAN WHAT IS ON THE LABEL WHICH LEADS TO THE ALLEGATION OF THE LABELING BEING WRONG. THE USER FELT THAT THE LABELING MUST BE INCORRECT SINCE THE FRENCH SIZE WAS NOT WHAT THEY EXPECTED. PER FOLLOW UP VIA EMAIL ON 03JAN022, THE ISSUE OCCURRED IN 2 UNITS FROM SAME LOT NUMBER JUFR2087.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003144 ↗
• MalfunctionApr 2, 2021Inadequate Instructions for Healthcare Professional; Insufficient Device Problem Information; Inadequate Instructions for Healthcare Professional; Insufficient Device Problem Information

  IT WAS REPORTED THAT FROM THE PICS AND DESCRIPTION, THE USER SEEMS THAT DIFFERENT GAUGE OF THE CATHETERS WERE INTO THE PACKAGING . THEY FOUND THIS IN 10 UNITS THAT ARE NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611077 ↗
• MalfunctionDec 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETERS DID NOT WORK FOR THE PATIENT SINCE THE PATIENT EXPERIENCED A LEAK.

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

  MAUDE report 11044467 ↗
• MalfunctionJun 9, 2020Fluid/Blood Leak; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT THE CATHETER BENT UPON INSERTION RESULTED IN URINE LEAK. IT WAS LATER REPORTED ON (B)(6) 2020 THE CUSTOMER STATED THAT THEY NOTICED THE CATHETER WAS BENT AND THE CATHETER LEAKED.

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

  MAUDE report 10135580 ↗
• MalfunctionJun 5, 2020Material Too Soft/Flexible; Fluid/Blood Leak; Material Twisted/Bent; Material Too Soft/Flexible

  IT WAS REPORTED THAT THE CATHETER BEND UPON INSERTION RESULTED IN URINE LEAK. PER FOLLOW UP, THE CUSTOMER STATED THAT THEY NOTICED THE CATHETER WAS BENT AND LEAKED.

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

  MAUDE report 10122907 ↗
• MalfunctionApr 3, 2020Difficult to Insert

  IT WAS REPORTED THAT THE PATIENTS MOTHER SAID THE CATHETER WAS SOMETIMES HARDER TO INSERT SINCE THE PATIENT WAS OLDER AND MOVING MORE. 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 9922427 ↗
• MalfunctionApr 1, 2020Break; Material Split, Cut or Torn; Break

  IT WAS REPORTED THAT THERE WERE SOME CATHETERS IN EVERY ORDER WHERE THE FUNNEL WAS TORN NOT COMPLETELY SEALED AT THE TOP, WHICH MADE THE MEDICINE LEAK.

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

  MAUDE report 9913957 ↗
• InjurySep 14, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY. THE PATIENT EXPERIENCED BLEEDING, INFLAMMATION, SWELLING, A UTI, AND A YEAST INFECTION. THE PATIENT HAS BEEN PRESCRIBED MEDICATION BY THEIR PHYSICIAN.

  Patient problems: Fungal Infection; Hemorrhage/Blood Loss/Bleeding; Inflammation; Swelling; Urinary Tract Infection

  MAUDE report 7876953 ↗