Magic3 Go Male Coude Catheter with SureGrip 50812GRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 00801741137013), received between May 29, 2018 and Apr 3, 2025 — classified as 15 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 20, 2023Class IIOpen, Classified

   Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

   Z-1699-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT ONE END OF THE INTERMITTENT CATHETER TUBE WAS NOT OPEN. PATIENT GOT PRODUCT THROUGH THEIR DOCTOR NOT LMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21761532 ↗
• MalfunctionFeb 7, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEAR THE EYELET OF MALE HYDROPHILIC INTERMITTENT CATHETER THERE WAS PART OF IT THAT WAS RAISED THAT HAD CAUSED HIM SOME DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 18658453 ↗
• MalfunctionJun 21, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CUSTOMER HAD TROUBLE WITH INTERMITTENT CATHETERS. THEY ORDERED 15 BOXES, AND SOME OF THE CATHETERS DID NOT ENTER THE BLADDER. 3.65 ML DID NOT ENTER, AND 3.43 ML DID ENTER. PER FOLLOW UP VIA EMAIL ON 01MAY2023, IT WAS REPORTED THAT THE CUSTOMER HAD GOOD THEY WORKED AND BAD THEY WOULD NOT ENTER THE BLADDER SAMPLES FROM TWO LOTS (LOT# JUGU0844) AND (LOT# JUGV1290). CUSTOMER CURRENTLY HAD TWELVE BOXES OF LOT # JUGV1290 AND BOUGHT 18 BOXES TOTALLY. PER SAMPLE RECEIVED ON 08MAY2023, IT WAS STATED THAT THE CUSTOMER RETURNED THREE ADDITIONAL USED INTERMITTENT CATHETERS SAMPLES FOR LOT# JUGU0844 AND THREE ADDITIONAL USED SAMPLES FOR LOT# JUGV1290.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170324 ↗
• InjuryJun 15, 2023Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem; Tear, Rip or Hole in Device Packaging; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THESE INTERMITTENT CATHETERS CAUSED PATIENT AN INFECTION AND WAS HOSPITALIZED AND CAUGHT TETANUS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR INFECTION AND TETANUS. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, IT WAS REPORTED THAT THE CUSTOMER RECEIVED A VOLUNTARY EMERGENCY NOTICE FROM BD REGARDING A RECALL FOR A NONCONFORMITY WITH THE MAGIC GO 14 FR CATHETERS. THEY WERE REPORTED IN A COMPANY-WIDE NOTICE AS HAVING NONSTERILE COUDE, AND THEY HAPPENED TO BE ONE OF THOSE IMPACTED BY IT. AT THE TIME, THEY WERE SENT OUT FROM 180 MEDICAL. THIS LED TO NUMEROUS BLADDER INFECTIONS AND SEPSIS, AND THIS MADE THINGS DIFFICULT FOR THEM AS THEY COULD NOT WALK. THEY STILL HAD SAMPLES AVAILABLE AND PROVIDED THE LOT#: JUGW1445.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 17134183 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CAREGIVER DID NOT SPECIFY THE TIMEFRAME OF THE URINARY TRACT INFECTION AND THEY THOUGHT INTERMITTENT CATHETER CAUSED URINARY TRACT INFECTION FOR PATIENT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17098147 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT THE PATIENT HAD A URINARY TRACT INFECTION. FROM USING THE MAGIC 3 GO MALE COUDE INTERMITTENT CATHETER. IT WAS UNKNOWN, WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17097897 ↗
• InjuryJun 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT A URINARY TRACT INFECTION ON (B)(6) 2023. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 17078412 ↗
• InjuryJun 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN URINARY TRACT INFECTION AND WAS ON ANTIBIOTIC. THEY THOUGHT IT MIGHT HAVE BEEN FROM RECALL.

  Patient problems: Urinary Tract Infection

  MAUDE report 17037886 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DID NOT SPECIFY THE TIMEFRAME OF THE URINARY TRACT INFECTION (UTI) WHILE USING THE MAGIC 3 MALE COUDE CATHETER. REPRESENTATIVE ADVISED TO THROW AWAY AND REPLACED. IT IS UNKNOWN WHAT MEDICAL INTERVENTION IS PROVIDED FOR URINARY TRACT INFECTION. PER FOLLOW UP VIA PHONE ON (B)(6) 2023, CUSTOMER EXPERIENCED A URINARY TRACT INFECTION (UTI) WITH USE OF THE CATHETERS AND HAD TO GO THROUGH ONE ROUND OF ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 17031907 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER CAUSED CANDIDIASIS. THE PATIENT DID NOT INDICATE WHETHER MEDICAL TREATMENT WAS SOUGHT. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR CANDIDIASIS.

  Patient problems: Fungal Infection

  MAUDE report 16223929 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO URINARY TRACT INFECTIONS AND SOME CLUMPS OF BLOOD BY USING THE INTERMITTENT CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

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

  MAUDE report 15796626 ↗
• MalfunctionSep 13, 2022Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD SOME ROUGH EDGES WHERE THE EYE OF THE CATHETER WAS LOCATED WHICH HAD MADE THE PATIENT SORE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Irritability

  MAUDE report 15410255 ↗
• MalfunctionDec 30, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY IN INSERTING THE MAGIC3 GO MALE COUDE CATHETER. THE PATIENT WENT TO THE DOCTOR AND EVEN THE DOCTOR WAS HAVING TROUBLE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCTS FOR MORE THAN 90 DAYS. IT IS UNKNOWN IF THE CATHETER PERFORMED ITS ESSENTIAL FUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120280 ↗
• MalfunctionMay 25, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE INTERMITTENT CATHETER HAD VARYING DIAMETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878027 ↗
• MalfunctionMay 14, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE INTERMITTENT CATHETERS DID NOT HAVE ENOUGH LUBRICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11825696 ↗
• MalfunctionMay 7, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT 10-15 PERCENTAGE OF THE MAGIC 3 GO MALE COUDE INTERMITTENT CATHETERS FROM THE LAST ORDER WERE NOT LUBRICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793833 ↗
• InjuryApr 7, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED BLEEDING AND URINARY TRACT INFECTION AND WOULD SPEAK WITH DOCTOR. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 11628393 ↗
• MalfunctionMar 5, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT FELT DIFFICULTY IN INSERTING THE MAGIC 3 GO MALE COUDE CATHETER. A MODERATE AMOUNT OF BLOOD WAS NOTED DURING WITHDRAWAL. ADDITIONALLY A SMALL AMOUNT OF BLOOD CAME OUT OF THE URETHRA FOR ONE MINUTE AFTER THE CATHETER WAS REMOVED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 11423991 ↗
• MalfunctionFeb 1, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE CATHETERS WERE DRY AND HAD NO LUBRICATION.

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

  MAUDE report 11263474 ↗
• MalfunctionJan 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE COUDE INTERMITTENT CATHETERS WERE DIFFICULT TO INSERT AND PATIENT THOUGHT THEY MAY BE TOO BIG.

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

  MAUDE report 11132030 ↗
• MalfunctionNov 3, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO CATHETERS WERE NOT HAVING THE LUBRICATION WHICH RESULTED IN DIFFICULTY DURING INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779098 ↗
• MalfunctionOct 23, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS HAD A WIDER DIAMETER THAN USUAL AND SEEMED CLOSER TO 14FR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731234 ↗
• MalfunctionOct 13, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE 12FR MAGIC3 GO CATHETERS WERE LARGER IN DIAMETER THAN THE CURE 12FR CATHETERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10674069 ↗
• MalfunctionOct 13, 2020Material Too Rigid or Stiff; Material Protrusion/Extrusion; Material Too Rigid or Stiff; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT SEAMLESS AT THE TIP AND HAD A BURR ON THE EYELET. ALSO STATED THAT PATIENT EXPERIENCED PAIN AND BLEEDING. NO MEDICAL INTERVENTION REPORTED. FOLLOW UP VIA PHONE ON 16OCT2020, THE CUSTOMER NOTED IT APPEARED THAT ABOUT AN INCH OF THE ¿SEALANT¿ WAS PROTRUDING AT END OF THE CATHETER. THE PATIENT REPORTEDLY DID NOT FEEL THE PROTRUSION WHEN INSERTING THE CATHETER BUT FELT IT WHEN THE CATHETER WAS BEING REMOVED. THE CATHETER REPORTEDLY CUT THE PATIENT¿S URETHRA AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REQUIRED. THE ENTIRE CATHETER WAS NOT AVAILABLE, BUT THE PATIENT DID CUT OFF THE END OF THE CATHETER WITH THE PROTRUSION AND THAT WAS AVAILABLE FOR RETURN.

  Patient problems: No Code Available; Pain

  MAUDE report 10671434 ↗
• MalfunctionSep 17, 2020Improper Chemical Reaction; Inadequate Lubrication; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE COUDE INTERMITTENT CATHETERS WERE NOT LUBRICATED AS THEY WERE IN PAST AND IT CAUSED PAIN AND DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 10547031 ↗