Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50612Recalls & reported problems

Summary

The FDA's MAUDE database contains 85 adverse event reports that list this exact device (DI 00801741068072), received between May 19, 2017 and Jul 14, 2025 — classified as 9 injuries, 76 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (14 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 85 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT NO LONGER LIKED THE INTERMITTENT CATHETER PRODUCT. THE PATIENT THINKS THEY WERE USING MORE SILICONE, MAKING IT FEEL TOO BIG FOR HIS ANATOMY. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493991 ↗
• MalfunctionApr 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WERE TWISTED AND UNUSABLE. PER CUSTOMER VIA PHONE ON 01APR2025, IT WAS REPORTED THAT THE CUSTOMER DOES NOT SEE VERY WELL AND THEY COULD NOT PROVIDE THE LOT NUMBER. THEY SAID A ONE OR TWO WERE TWISTED AND THEY COULD NOT USE THEM BUT THEY DID REPORT THE ISSUE. THEY REPLACED THE DEFECTIVE CATHETERS. THEY DID ASK ABOUT GETTING SAMPLES FOR DIFFERENT BRANDS OF CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797386 ↗
• MalfunctionMar 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID SOME TIPS ARE DEFORMED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632624 ↗
• MalfunctionJan 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID A FEW INTERMITTENT CATHETERS ON PREVIOUS ORDER WERE BENT OR TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054164 ↗
• MalfunctionNov 15, 2024Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT A COUPLE OF INTERMITTENT CATHETERS DID NOT HAVE EYELETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20694035 ↗
• MalfunctionOct 24, 2024Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE STERILE PACKAGE OF INTERMITTENT CATHETER HAD CONTAMINATION IN IT. PATIENT COULD NOT USE THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 05DEC2024, STATED THAT THE PART OF THE OUTER PACKAGING WAS GETTING INSIDE OF THE CATHETER AND CAUSED IT TO BE NON- STERILE. THE CUSTOMER COULD SEE THE WHITE PIECE OF THE PLASTIC IN THE CATHETER, AND THEY DID NOT USE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522512 ↗
• MalfunctionJun 3, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER FOR EACH ORDER 4 OR 5 OF THE CATHETERS WERE BENT AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 19446391 ↗
• InjuryApr 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION DUE TO KIDNEY STONES OR INTERMITTENT CATHETER. THE PATIENT WAS PRESCRIBED ANTIBIOTIC. PER CUSTOMER VIA PHONE ON (B)(6) 2024, IT WAS REPORTED THAT THE CUSTOMER DID DEVELOP A URINARY TRACT INFECTION BUT WAS UNSURE IF IT WAS FROM THE KIDNEY STONES OR CATHETERS. THE CUSTOMER WAS PRESCRIBED ANTIBIOTICS FOR THE URINARY TRACT INFECTION AND WAS STILL USING THE CATHETERS.

  Patient problems: Urinary Tract Infection

  MAUDE report 19095535 ↗
• MalfunctionApr 12, 2024Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE LUBRICANT IN THE INTERMITTENT CATHETER WAS NOT THICK ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095373 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD 2 URINARY TRACT INFECTIONS. PATIENT WAS USING INTERMITTENT CATHETER 6 TIMES A DAY. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 18535871 ↗
• MalfunctionJul 26, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD ABOUT 3 CATHETERS THAT HAD A CROOKED TIP AND PATIENT STATED IT WAS SIDEWAYS AND PATIENT DISCARDED. REPRESENTATIVE ADVISED PATIENT WHEN PATIENT HAS DEFECTIVE PRODUCTS TO LET REPRESENTATIVE KNOW SO REPRESENTATIVE CAN FIX IT. REPRESENTATIVE SENT 3 REPLACEMENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17396249 ↗
• MalfunctionJun 20, 2023Short Fill; Short Fill

  IT WAS REPORTED THAT ABOUT 20 CATHETERS DID NOT HAVE SALINE IN THE PACKET, AND PATIENT HAD TO THROW THEM AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17163524 ↗
• InjuryJun 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION, NOT SURE WHAT CAUSED. USING MULTIPLE INTERMITTENT CATHETERS AFFECTED KIDNEYS AND CAUSED BACTERIAL INFECTIONS OF STOMACH AND INTESTINES. THIS CAUSED HOSPITALIZED. REPRESENTATIVE SENT REPLACEMENTS. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 17085938 ↗
• MalfunctionMay 18, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE TOO MESSY TO USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16959307 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COULD NOT USE THESE INTERMITTENT CATHETER AS THE PATIENT GOT MASSIVE INFECTION AND GOT HOSPITALIZED. PATIENT NOT GOING TO USE THIS STYLE OF CATHETERS ANYMORE. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE INFECTION AT THIS TIME AND MEDICAL INTERVENTION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 15438131 ↗
• MalfunctionAug 1, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE HARD TO INSERT AND WOULD NOT GO ALL THE WAY IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15139511 ↗
• MalfunctionMar 7, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETER TIPS WERE LONG AND SOME WERE SHORT. ALSO STATED THAT THE PATIENT HAD 10 DEFECTIVE CATHETERS THAT THEY CAN'T USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685684 ↗
• MalfunctionMar 7, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE COUDE INTERMITTENT CATHETER TIPS THAT WERE LONG AND SOME WERE SHORT. ALSO STATED THAT PATIENT HAD 10 DEFECTIVE CATHETERS THAT CAN'T USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13685537 ↗
• MalfunctionFeb 18, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATED THAT WHEN TAKING THE COUDE INTERMITTENT CATHETER OUT OF THE BODY, THERE WAS A SNAG AT THE DRAINAGE EYE OPENING. ALSO PATIENT SAID THAT IT WAS PAINFUL. IT WAS NOTED THAT THE PATIENT HAD BEEN USING PRODUCTS MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 13560039 ↗
• MalfunctionNov 9, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT SOME OF THE INTERMITTENT CATHETERS CAME TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783096 ↗
• MalfunctionMay 6, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETERS ARE NOT WELL LUBRICATED AND CAUSED DISCOMFORT TO THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 11784140 ↗
• MalfunctionOct 15, 2020Component Misassembled; Component Missing; Material Twisted/Bent; Component Misassembled

  IT WAS REPORTED THAT THE SOME CATHETERS WERE MISSING EYELETS AND WERE ALSO BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684296 ↗
• MalfunctionOct 15, 2020Component Missing; Material Twisted/Bent

  IT WAS REPORTED THAT THE SOME CATHETERS WERE MISSING EYELETS AND WERE ALSO BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10684289 ↗
• MalfunctionOct 9, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE FIVE OF THE INTERMITTENT CATHETERS HAD NO EYELETS, AND OTHER WERE BENT AND CURVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658884 ↗
• MalfunctionOct 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE FIVE OF THE INTERMITTENT CATHETERS HAD NO EYELETS, AND OTHER WERE BENT AND CURVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658875 ↗