Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53610GRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741069758), received between May 9, 2017 and Nov 24, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER WAS REACHING OUT BECAUSE THEY HAVE NOTICED ONGOING ISSUES WITH THE CATHETERS THEY RECEIVED. THE SIZES HAVE BEEN INCONSISTENT FROM ONE CATHETER TO ANOTHER, EVEN THOUGH THEY WERE LABELED AS THE SAME SIZE. THIS INCONSISTENCY WAS CAUSING DISCOMFORT AND MAKING IT DIFFICULT TO USE THEM SAFELY AND PROPERLY. THEY WOULD APPRECIATE IT IF THEY COULD LOOK INTO THIS ISSUE AND ADVISE ON HOW IT COULD BE RESOLVED.

  Patient problems: Discomfort

  MAUDE report 23639923 ↗
• MalfunctionNov 6, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT INTERMITTENT CATHETER WAS DAMAGED WITH BLACK STAINS INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490133 ↗
• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER COATING WAS UNEVEN OVER CATHETER SURFACE, BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091906 ↗
• MalfunctionJun 23, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS WERE IRREGULARLY SIZED AND ARE TOO FLIMSY AND THIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051063 ↗
• MalfunctionNov 6, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THESE CATHETERS WERE CAUSING BLEEDING DUE TO A LACK OF LUBRICITY. ALSO STATED PATIENT USED EXTRA LUBRICANT AND A TWISTING MOTION AND THAT HELPED TO STOP THE ISSUE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Code Available

  MAUDE report 10802608 ↗
• MalfunctionMay 27, 2020Improper Chemical Reaction; Improper Chemical Reaction; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE CATHETER WAS TOO STICKY AND SOMETIMES THE LUBRICATION WAS NOT EVEN DURING INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 10091525 ↗
• MalfunctionDec 25, 2019Product Quality Problem; Product Quality Problem; Component Missing

  IT WAS REPORTED THAT THERE WAS NO LUBRICATION ON THE MAGIC 3 CATHETER.

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

  MAUDE report 9517467 ↗
• MalfunctionDec 25, 2019Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE MAGIC 3 CATHETERS WERE BENT AND UNABLE TO BE USED.

  Patient problems: No Patient Involvement

  MAUDE report 9517466 ↗
• MalfunctionDec 25, 2019Gel Leak; Burst Container or Vessel; Gel Leak; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE PATIENT BELIEVED THE BURST PACKET INSIDE THE CATHETER PACKAGING WAS ALREADY BUST OR HAD DRIED UP.

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

  MAUDE report 9517464 ↗
• MalfunctionAug 2, 2018Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETERS WERE BENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7743907 ↗
• MalfunctionJul 19, 2018Break; Material Twisted/Bent; Break

  IT WAS REPORTED THAT THERE WAS NO TIP ON THE MAGIC 3 CATHETER. THE TIP OF THE CATHETER WAS SQUARED OFF COMPLETELY.

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

  MAUDE report 7704243 ↗
• MalfunctionOct 31, 2017Component Missing

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6990372 ↗
• MalfunctionMay 16, 2017Component Missing; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6571305 ↗
• MalfunctionMay 15, 2017Scratched Material

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS ROUGH. SUBSEQUENTLY, THE PATIENT ALLEGEDLY EXPERIENCED BLEEDING; HOWEVER, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6568319 ↗
• MalfunctionMay 10, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS NOT GETTING LUBRICATED PROPERLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6559160 ↗
• MalfunctionMay 9, 2017Burst Container or Vessel; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE WATER PACKET APPEARED TO HAVE BEEN POPPED WHEN THE CUSTOMER RECEIVED IT.

  Patient problems: No Information

  MAUDE report 6554128 ↗