Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53612GRecalls & reported problems

Summary

The FDA's MAUDE database contains 161 adverse event reports that list this exact device (DI 00801741069765), received between Jun 9, 2017 and Sep 22, 2025 — classified as 20 injuries, 141 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (38 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 25 most recent of 161 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2025Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID THAT SEVERAL CATHETERS HAD COATING WHICH RENDERS THEM UNUSABLE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108529 ↗
• InjurySep 2, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETERS HAD A REALLY SHARP WEDGE ON IT WHICH CUT HIM INTERNALLY AND CAUSED A LOT OF BLEEDING. HE IS CURRENTLY BEING MONITORED FOR POSSIBLE INFECTION/SERIOUS DAMAGE THAT WAS DONE TO HIM. LET HIM KNOW THAT WOULD LOG THE COMPLAINT. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 22937733 ↗
• InjuryJul 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A COUPLE UTI'S BUT NOT SURE IF FROM CATHING. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS PROVIDED NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22437155 ↗
• InjuryMar 27, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT PATIENT SAID THERE WAS A BUMP ON THE BOTTOM SIDE. THERE WAS ALSO A SHARP DEFORMITY AT THE TIP THAT CAUSED BLEEDING AND CAUSED PATIENT TO GET A URINARY TRACT INFECTION. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

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

  MAUDE report 21709684 ↗
• MalfunctionMar 27, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT PATIENT SAID THERE WAS A BUMP ON THE BOTTOM SIDE. THERE WAS ALSO A SHARP DEFORMITY AT THE TIP THAT CAUSED BLEEDING AND CAUSED PATIENT TO GET A URINARY TRACT INFECTION. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707286 ↗
• MalfunctionFeb 19, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE BURST PACKETS IN THE INTERMITTENT CATHETER WERE EMPTY AND SOME CATHETERS WERE BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21410084 ↗
• MalfunctionJan 13, 2025Gel Leak; Gel Leak

  IT WAS REPORTED PATIENT STATED A FEW INTERMITTENT CATHETERS HAD NOT ENOUGH LIQUID IN THE PACKET AND A COUPLE WERE TWISTED. PER CUSTOMER VIA PHONE ON 17DEC2024, IT WAS REPORTED THAT 8 OF THE CATHETERS WERE EITHER BENT SO BADLY ON THE ENDS THAT THEY COULD NOT USE THEM ORE THE FLUID HAD LEAK ALL THE WAY OUT AND THEY COULD NOT USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21136882 ↗
• MalfunctionJan 7, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD AN UNEVEN COATING ON THE CATHETER SURFACE BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091644 ↗
• MalfunctionDec 30, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT RECEIVED BENT INTERMITTENT CATHETERS AND CATHETERS WITHOUT LUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034869 ↗
• MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT PATIENT RECEIVED BENT INTERMITTENT CATHETERS AND CATHETERS WITHOUT LUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21034425 ↗
• MalfunctionNov 25, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THE INTERMITTENT CATHETER HOLE WAS NOT PUNCHED ALL THE WAY THROUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20770725 ↗
• MalfunctionSep 19, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE 5 BURST PACKETS OF MAGIC 3 GO HYDROPHILIC INTERMITTENT CATHETER WERE EMPTY AND BENT AND TWISTED TOO. PER CUSTOMER VIA PHONE ON 17DEC2024, IT WAS REPORTED THAT 8 OF THE CATHETERS WERE EITHER BENT SO BADLY ON THE ENDS THAT CUSTOMER COULD NOT USE THEM, OR THE FLUID HAD LEAKED ALL THE WAY OUT AND COULD NOT USE THEM .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20258135 ↗
• MalfunctionAug 14, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE GRIPPER SLEEVES WERE TOO BIG AND KEPT COMING OFF OF THE INTERMITTENT CATHETERS AND CUSTOMERS HAD LOSE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982101 ↗
• MalfunctionMay 22, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT CURRENTLY USING MAGIC3¿ HYDROPHILIC INTERMITTENT CATHETERS. PATIENT STATED AT TIMES WHEN REMOVING CATHETER, IT CAME OUT DRY CAUSED IRRITATION (PCN#53614G AND PCN#53612G). PATIENT HAD BEEN USING WATER PACKETS FROM SAMPLE CATHETERS (CONVATEC HM12 AND GENTLECATH GLIDE) SENT TO THEM FROM THEIR MEDICAL SUPPLY COMPANY INSTEAD OF THE BD PACKET AS THEY WERE LARGER. PATIENT STATED THIS CAUSED BETTER LUBRICATION FOR INSERTION AND REMOVAL. PATIENT INQUIRED IF BD HAD STERILE WATER PACKETS THAT CAN BE ORDERED. ALSO ASKED TO USE THE STERILE WATER SALINE USED FOR IRRIGATION BE USED WITH THEIR HYDROPHILIC CATHETER. REPRESENTATIVE RESPOND DID NOT USE SALINE AS IT WAS COMMONLY CALLED SALTWATER. STERILE WATER PACKETS MAY BE PURCHASED FROM THEIR MEDICAL SUPPLIER. REVIEWED HOW TO GUIDE WITH PATIENT TO CONFIRM PROPER LUBRICATION OF CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 19372254 ↗
• MalfunctionApr 15, 2024Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT PATIENT FELT LIKE A PIECE OF PLASTIC IN INTERMITTENT CATHETERS THAT SCRAPES/SCRATCHES. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 19106218 ↗
• MalfunctionMar 13, 2024Component Missing; Component Misassembled; Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS MISSING THE SURE-GRIP SLIDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18893770 ↗
• MalfunctionFeb 20, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE BOTH HOLE AT THE END OF THE INTERMITTENT CATHETER. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739427 ↗
• MalfunctionJan 10, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE MAGIC 3 GO HYDROPHILIC INTERMITTENT CATHETER HAD NO LUBRICANT OR PACKETS OF LUBE WERE BARELY FILLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18484114 ↗
• MalfunctionSep 28, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT TWO OF THE INTERMITTENT CATHETERS WERE BENT AND TWO INTERMITTENT CATHETERS RECEIVED WITHOUT LUBE. PER FOLLOW UP VIA PHONE ON 22SEP2023, CUSTOMER STATED THAT THE CATHETER BENT AS THEY WAS INSERTING THE CATHETER. CUSTOMER WAS ABLE TO FULLY INSERT AND VOID WITH THE CATHETERS BUT FELT A SCRATCHING SENSATION. NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT IT ONLY HAPPENED TWO TIME. ALSO, THERE WERE TWO INCIDENTS WHERE THERE WAS NO LUBRICANT IN THE PACKAGE JUST AIR.

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

  MAUDE report 17834057 ↗
• MalfunctionJul 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED SOME OF THE INTERMITTENT CATHETER THAT WERE EATEN AT THE TOP IN THE LAST 2 ORDERS. STATED THAT THE CATHETER WAS ¿SPLIT- CHEWED¿ IN THE END (LOT# JUGW0773, LOT# JUGT1003).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17342027 ↗
• MalfunctionJul 18, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED SOME OF THE INTERMITTENT CATHETER THAT WERE EATEN AT THE TOP IN THE LAST 2 ORDERS. STATED THAT THE CATHETER WAS ¿SPLIT- CHEWED¿ IN THE END (LOT# JUGW0773, LOT# JUGT1003).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341905 ↗
• MalfunctionJul 5, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE SOME MAGIC 3 MALE CATHETERS DID NOT HAVE HOLES TO DRAIN. REPLACEMENT PLACED FOR 20 CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262083 ↗
• MalfunctionJun 7, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT CUSTOMER NOTICED WHILE OPENING THE BOX OF INTERMITTENT CATHETER WITH LOT# JUGX1192, CONTENTS APPEARED TO BE PACKED IMPROPERLY AND ALSO REPORTED THAT THE NON-INSERTION END OF THE CATHETERS ARE JAGGED AND DID NOT LUBRICATE LIKE THEY SHOULD AND CAUSED MINOR BLEEDING AND DISCOMFORT. CUSTOMER SERVICE HAD BEEN NOTIFIED BECAUSE THEY WERE UNABLE TO TRANSFER TO THEM THIS MORNING, AND THEY HAVE BEEN ASKED TO CONTACT PATIENT TO DO AN EXCHANGE OF THIS PRODUCT. PATIENT HAD USED A FEW OUT OF ONE BOX AND HAS AN ENTIRE UNOPENED BOX OF THE SAME LOT#. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 17077941 ↗
• MalfunctionMay 26, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE PACKED IMPROPERLY WHEN THEY OPENED THE BOX. THE END TIPS, OPPOSITE OF THE INSERTION END, ARE JAGGED AND NOT CUT PROPERLY. THE PATIENT STATED THAT THEY APPEAR TO NOT BE LUBRICATING CORRECTLY AND HAVE CAUSED MINOR BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 17009961 ↗
• MalfunctionMay 25, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER NOTICED WHILE OPENING THE BOX OF INTERMITTENT CATHETER WITH LOT# JUGX1192, CONTENTS APPEARED TO BE PACKED IMPROPERLY AND ALSO REPORTED THAT THE NON-INSERTION END OF THE CATHETERS ARE JAGGED AND DID NOT LUBRICATE LIKE THEY SHOULD AND CAUSED MINOR BLEEDING AND DISCOMFORT. CUSTOMER SERVICE HAD BEEN NOTIFIED BECAUSE THEY WERE UNABLE TO TRANSFER TO THEM THIS MORNING AND THEY HAVE BEEN ASKED TO CONTACT PATIENT TO DO AN EXCHANGE OF THIS PRODUCT. PATIENT HAD USED A FEW OUT OF ONE BOX AND HAS AN ENTIRE UNOPENED BOX OF THE SAME LOT#.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002382 ↗