Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 52608GRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741069680), received between Nov 1, 2017 and Jan 7, 2025 — classified as 2 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT BEFORE USE, THERE WAS UNEVEN COATING ON SURFACE OF THE INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21092479 ↗
• InjuryMay 24, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN A PMCF THAT "NO, THEY WERE NOT ABLE TO SUCCESSFULLY CATHETERIZE THE PATIENT ON THE FIRST ATTEMPT BECAUSE "PATIENTS HAD TO BE PUT UNDER ANESTHESIA" IN RELATION TO 52608G MAGIC3® INTERMITTENT HYDROPHILIC CATHETER WITH SURE-GRIP¿ SLEEVE PEDIATRIC.

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

  MAUDE report 19393686 ↗
• MalfunctionJun 12, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS HAVING TROUBLE WITH INSERTION WITH THESE MAGIC 3 INTERMITTENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17102913 ↗
• MalfunctionDec 22, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE BENT, AND THE PATIENT HAD TO THROW THEM AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16033451 ↗
• MalfunctionOct 27, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THESE MAGIC 3 HYDRO INTERMITTENT CATHETERS HAD BEEN HURTING THE PATIENT AND EVEN THROUGH THEY WERE THE SAME SIZE AS THE (52808G-MAGIC3 GO PEDIATRIC CATHETER) ON BACK ORDER AND THE ONES SENT SEEMED BIGGER IN FRENCH SIZE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 15679989 ↗
• MalfunctionApr 13, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER FR SIZE WAS BIGGER THAN THE PATIENT USED AND IT CAUSED PAIN UPON INSERTION. NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Pain

  MAUDE report 14106545 ↗
• MalfunctionJul 7, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT SOMETIMES IT WAS DIFFICULT TO INSERT AND WITHDRAW THE MAGIC 3 HYDRO CATHETERS AND THE COMPLAINANT THOUGHT THAT THEY MIGHT BE TOO BIG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12132474 ↗
• MalfunctionDec 21, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE USER EXPERIENCED AN ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER WHICH WAS FOUND TO BE CRACKED OR ALREADY CRACKED WHEN OPENING THE PACKAGE. THE CATHETERS ARE USED TWICE A DAY TO INJECT DRUGS INTO THE BLADDER. IT WAS ALSO REPORTED THAT THE SIZE (CH) WAS VARIED WITHIN THE SAME BOX. IT WAS REPORTED ON DIFFERENT BATCHES AND ON CATHETERS IN THE SAME BATCH. SOMETIMES THE INTERMITTENT CATHETERS WERE SMALLER THAN CH 08, AND THEN IT BENDS WHEN THE USER TRIES TO INSERT IT. IT WAS ALSO REPORTED THAT THE CATHETERS WERE A LITTLE THICKER.

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

  MAUDE report 11044518 ↗
• MalfunctionDec 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE USER HAD OFTEN EXPERIENCED THE ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER WHICH WAS FOUND TO BE CRACKED OR WAS CRACKED PRIOR OPENING THE PACKAGE. THEY INJECTED DRUGS INTO THE BLADDER AND THEREFORE USED THE CONE MORNING AND EVENING. THEY ALSO FELT THE SIZE (CH) VARIED WITHIN THE SAME BOX. IT WAS NOTICED ON DIFFERENT BATCHES BUT OBSERVED WITHIN THE SAME BATCH AS WELL AND SEEMS A BIT RANDOM. SOMETIMES THE INTERMITTENT CATHETER WAS SMALLER THAN CH08 AND THEN IT BENDS WHEN THE USER TRIED TO INSERT IT, AS IF IT WAS TOO WEAK. SOMETIMES IT WAS LITTLE THICKER AS WELL.

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

  MAUDE report 11044517 ↗
• MalfunctionDec 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE USER HAD OFTEN EXPERIENCED THE ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER, WHICH WAS FOUND TO BE CRACKED OR ALREADY CRACKED WHEN THEY OPEN THE PACKAGE. THEY INJECT THE DRUGS INTO THE BLADDER AND THEREFORE USED THE CONE IN THE MORNING AND EVENING. THEY ALSO FEEL THAT THE SIZE (CH) WAS VARIED WITHIN THE SAME BOX. IT HAS BEEN ON DIFFERENT BATCHES, BUT ALSO WITHIN THE SAME BATCH, IT SEEMS A BIT RANDOM. SOMETIMES THE INTERMITTENT CATHETERS WERE SMALLER THAN CH 08, AND THEN IT BENDS WHEN THE USER TRIED TO INSERT IT, AS IT WAS TOO WEAK. ALSO, SOMETIMES IT WAS A LITTLE THICKER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11044486 ↗
• MalfunctionDec 21, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE USER HAD OFTEN EXPERIENCED THE ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER, WHICH WAS FOUND TO BE CRACKED OR ALREADY CRACKED WHEN THEY OPEN THE PACKAGE. THEY INJECT THE DRUGS INTO THE BLADDER AND THEREFORE USED THE CONE IN THE MORNING AND EVENING. THEY ALSO FEEL THAT THE SIZE (CH) WAS VARIED WITHIN THE SAME BOX. IT HAS BEEN ON DIFFERENT BATCHES, BUT ALSO WITHIN THE SAME BATCH, IT SEEMS A BIT RANDOM. SOMETIMES THE INTERMITTENT CATHETERS WERE SMALLER THAN CH 08, AND THEN IT BENDS WHEN THE USER TRIED TO INSERT IT, AS IT WAS TOO WEAK. ALSO, SOMETIMES IT WAS A LITTLE THICKER.

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

  MAUDE report 11044483 ↗
• MalfunctionDec 18, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE USER HAD OFTEN EXPERIENCED THE ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER WHICH WAS FOUND TO BE CRACKED OR WAS CRACKED PRIOR OPENING THE PACKAGE. THEY INJECTED DRUGS INTO THE BLADDER AND THEREFORE USED THE CONE MORNING AND EVENING. THEY ALSO FELT THE SIZE (CH) VARIED WITHIN THE SAME BOX. IT WAS NOTICED ON DIFFERENT BATCHES BUT OBSERVED WITHIN THE SAME BATCH AS WELL AND SEEMS A BIT RANDOM. SOMETIMES THE INTERMITTENT CATHETER WAS SMALLER THAN CH08 AND THEN IT BENDS WHEN THE USER TRIED TO INSERT IT, AS IF IT WAS TOO WEAK. SOMETIMES IT WAS LITTLE THICKER AS WELL.

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

  MAUDE report 11039825 ↗
• MalfunctionDec 18, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE USER HAD OFTEN EXPERIENCED THE ISSUE WITH THE CONE ON THE INTERMITTENT CATHETER WHICH WAS FOUND TO BE CRACKED OR WAS CRACKED PRIOR OPENING THE PACKAGE. THEY INJECTED DRUGS INTO THE BLADDER AND THEREFORE USED THE CONE MORNING AND EVENING. THEY ALSO FELT THE SIZE (CH) VARIED WITHIN THE SAME BOX. IT WAS NOTICED ON DIFFERENT BATCHES BUT OBSERVED WITHIN THE SAME BATCH AS WELL AND SEEMS A BIT RANDOM. SOMETIMES THE INTERMITTENT CATHETER WAS SMALLER THAN CH08 AND THEN IT BENDS WHEN THE USER TRIED TO INSERT IT, AS IF IT WAS TOO WEAK. SOMETIMES IT WAS LITTLE THICKER AS WELL.

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

  MAUDE report 11039796 ↗
• MalfunctionJul 30, 2019Material Twisted/Bent; Packaging Problem

  IT WAS REPORTED THAT TWO OF THE CATHETERS WERE BENT AND NOT ABLE TO BE USED AS A RESULT OF BEING CRAMMED INTO THE BOX. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8842935 ↗
• MalfunctionApr 17, 2019Short Fill; Component Missing; Short Fill

  IT WAS REPORTED THAT THE WATER SACHET OF THE MAGIC 3 CATHETER WAS EMPTY.

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

  MAUDE report 8525066 ↗
• MalfunctionFeb 1, 2019Difficult to Insert; Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER WAS NOT SUFFICIENTLY MOISTURIZED AND RESULTED IN DIFFICULTY DURING INSERTION. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17 JANUARY 2019 FROM IBC REPRESENTATIVE, THE LACK OF MOISTURE ALLEGEDLY CAUSED THE DIFFICULTY DURING INSERTION.

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

  MAUDE report 8297738 ↗
• MalfunctionFeb 1, 2019Inaccurate Flow Rate; No Flow; Inaccurate Flow Rate

  IT WAS REPORTED THAT URINE DID NOT FLOWING PROPERLY FROM THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE IBC REPRESENTATIVE ON 11-JAN-2019, THE CATHETER WAS CONGESTED AND URINE COULD NOT GO THROUGH SO RAN OUTSIDE AND AROUND THE CATHETER.

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

  MAUDE report 8297248 ↗
• InjuryNov 28, 2017Sticking

  IT WAS REPORTED THAT THE CATHETER BECAME STUCK IN THE PATIENT'S URETHRA. THE PATIENT DID NOT EXPERIENCE ANY DIFFICULTY INSERTING THE CATHETER. THE PATIENT WENT TO THE EMERGENCY ROOM WHERE A BACKFLUSH WAS PERFORMED TO REMOVE THE CATHETER.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 7063299 ↗
• MalfunctionNov 1, 2017Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY AND THAT THE CATHETER TIP SEEMED WIDER THAN USUAL. AS A RESULT, THE COMPLAINANT REPORTED THAT THEY WERE UNABLE TO INSERT THE CATHETER.

  Patient problems: No Information

  MAUDE report 6992737 ↗
• MalfunctionNov 1, 2017Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY AND THAT THE CATHETER TIP SEEMED WIDER THAN USUAL. AS A RESULT, THE COMPLAINANT REPORTED THAT THEY WERE UNABLE TO INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6992714 ↗