Magic3 Go Male Catheter with SureGrip 53816GRecalls & reported problems

Summary

The FDA's MAUDE database contains 164 adverse event reports that list this exact device (DI 00801741136979), received between May 15, 2018 and Jul 2, 2025 — classified as 43 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (35 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 164 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT SAID THAT HE HAS AN INFECTION AND WAS WONDERING IF IT COULD BE COMING FROM BARD CATHETERS. REP ASKED IF THE WRAPPING WAS OPENED AND ADVISED HIM THE CATHETERS ARE STERILE AND IF THE PKG WAS OPENED IT COULD POSSIBLY CAUSE CONTAMINATION. BUT HE SAID THEY WERE NOT OPENED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 22383302 ↗
• MalfunctionMar 21, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE INTERMITTENT CATHETER STUCK IN THE PLASTIC BAG AND THE PATIENT TRIED TO USE BUT THEY ARE TOO DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662951 ↗
• MalfunctionMar 18, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS TOO WET AND SLIPPERY FOR PATIENT TO INSERT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632292 ↗
• MalfunctionMar 17, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT STATED CATHETERS DO NOT HAVE ENOUGH LUBE. PATIENT EMAIL: (B)(6). (CASE # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617742 ↗
• MalfunctionJan 6, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PATIENT SAID THE INTERMITTENT CATHETER WAS TOO SHORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078437 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLADDER OR URINARY TRACT INFECTION EVERY 2 MONTHS FOR THE PAST 12 MONTHS AND HAD MEDICATION PRESCRIBED BY DOCTOR.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17286734 ↗
• InjuryJun 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO SEVERE URINARY TRACT INFECTIONS. PATIENT STATED THAT WITH ONE PATIENT WAS NOT ABLE TO PEE AND ALMOST STROKED OUT AND DIED. PATIENT STATED THAT PATIENT THEN GOT A URINARY TRACT INFECTION AND ALMOST DIED IN MARCH, PATIENT WAS GIVEN A 2-MONTH SUPPLY OF ANTIBIOTICS AND SEEMS TO BE ON THE MEND.

  Patient problems: Urinary Tract Infection

  MAUDE report 17142690 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A BLADDER INFECTION AND URINARY TRACT INFECTION. PATIENT WAS HOSPITALIZED AND ON ANTIBIOTICS (LOT#JUGU1957 AND LOT#JUGT1013).

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17106259 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER (LOT# JUGT1013 , LOT# JUGU1957 ) WAS CAUSING BLADDER INFECTION AND URINARY TRACT INFECTION. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17098158 ↗
• 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 BLADDER INFECTION AND URINARY TRACT INFECTION. PATIENT WAS HOSPITALIZED AND ON ANTIBIOTICS (LOT#JUGU1957 AND LOT#JUGT1013).

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17097303 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE URINARY TRACT INFECTION WAS SO SEVERE, WENT INTO BLOOD STREAM STARTING BACK IN DECEMBER AND THE MOST RECENT STARTED MARCH.

  Patient problems: Urinary Tract Infection

  MAUDE report 17031408 ↗
• InjuryMay 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE URINARY TRACT INFECTION WAS SO SEVERE, WENT INTO BLOOD STREAM STARTING BACK IN DECEMBER AND THE MOST RECENT STARTED MARCH.

  Patient problems: Urinary Tract Infection

  MAUDE report 17030582 ↗
• InjuryMay 30, 2023Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT HAD 3 URINARY TRACT INFECTION IN THE LAST 12 MONTHS AND WAS HOSPITALIZED FOR IT. THE CUSTOMER STATED URINARY TRACT INFECTIONS WERE FROM URINE BACKING UP. THE PATIENT WAS NOT SURE IF IT BACKED UP ALL THE WAY INTO THE KIDNEYS BUT WAS TO THE POINT PATIENT COULD NOT CATHETER. IT WAS UNKNOWN IF THE MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 17018944 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT STATED THAT THE PATIENT GOT A URINARY TRACT INFECTION IN JANUARY AND IT TURNED INTO A PROSTATE INFECTION USING INTERMITTENT CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION. PER FOLLOW UP VIA PHONE ON 02JUN2023, IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION WITH USE AND HAD TO BE OFF OF WORK FOR 3 DAYS. STATED THAT THE PATIENT WAS PRESCRIBED AN UNKNOWN ANTIBIOTIC FOR THE URINARY TRACT INFECTION.

  Patient problems: Unspecified Infection; Urinary Tract Infection

  MAUDE report 17018940 ↗
• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETERS ON THE RECALL LIST GAVE THE PATIENT BLADDER ISSUES. THEY SAID THAT THEY STILL HAD A FULL BOX OF 30 AND EXTRA 9 CATHETERS LEFT AND WANTED TO KNOW WHAT TO DO WITH THEM. REPRESENTATIVE ADVISED THEM TO DISCARD. THEY DID NOT SPECIFY THE TIMEFRAME OF THE ISSUE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 17018864 ↗
• InjuryMay 26, 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. PATIENT STATED THAT URINARY TRACT INFECTION DID DEVELOP. PATIENT WAS GIVEN ANTIBIOTICS 10-DAY REGIMEN. PATIENT STOPPED USING INTERMITTENT CATHETER.

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

  MAUDE report 17009630 ↗
• InjuryMay 22, 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. PATIENT STATED THAT HE HAD GOTTEN A URINARY TRACT INFECTION WHEN USING THE INTERMITTENT CATHETERS ON THE RECALL LIST. PATIENT SAID THAT PATIENT HAD TO GO TO CRITICAL CARE WAS TREATED FOR A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 16973707 ↗
• MalfunctionMay 2, 2023Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE SURE SLEEVE DID NOT WORK OR SLIDE CORRECTLY ON 6 CATHETERS. NO ADDITIONAL INFORMATION PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16853154 ↗
• MalfunctionFeb 1, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT STATED THAT LAST SHIPMENT OF THE MAGIC 3 GO MALE INTERMITTENT CATHETERS WERE PRETTY DRY. THE REPRESENTATIVE OFFERED TO CHANGE THEM TO DIFFERENT CATHETER BUT THE PATIENT SAID NO AND WOULD TRY THEM AGAIN FOR NEXT ORDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16277708 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WAS PAINFUL TO USE AND CAUSED BLEEDING AND A URINARY TRACT INFECTION, AND THEY DID SEEK MEDICAL ATTENTION. THIS WAS THEIR FIRST TIME USING THIS PRODUCT.

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

  MAUDE report 16264305 ↗
• MalfunctionJan 13, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MALE INTERMITTENT CATHETER WAS SCRATCHING THE PATIENT AND DRY WHEN USED .THE PATIENT STATED THEY DID NOT COME AS LUBRICATED AND THOUGHT THEY WOULD OR DID NOT HAVE ANY AT ALL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16156980 ↗
• MalfunctionJan 13, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE MALE INTERMITTENT CATHETER WAS SCRATCHING THE PATIENT AND DRY WHEN USED .THE PATIENT STATED THEY DID NOT COME AS LUBRICATED AND THOUGHT THEY WOULD OR DID NOT HAVE ANY AT ALL. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion

  MAUDE report 16156801 ↗
• MalfunctionJan 3, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO INSERT THE INTERMITTENT CATHETERS AND THEY INFORMED TO USE THE COUDE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086151 ↗
• MalfunctionDec 28, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT SOME OF THE INTERMITTENT CATHETERS DID NOT HAVE ENOUGH LUBRICANT OR WERE DRIED OUT. THE PATIENT WANTED EXTRA LUBRICANT SENT SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16062978 ↗
• MalfunctionDec 16, 2022Component Misassembled; Material Split, Cut or Torn; Component Misassembled; Material Split, Cut or Torn

  IT WAS REPORTED THAT SOME OF THE INTERMITTENT CATHETERS WERE NOT LUBRICATED AND IT TOOK TOO LONG TO DRAIN. AS PER FOLLOW UP VIA PHONE ON 29NOV2022, IT WAS REPORTED THAT THE CUSTOMER WAS STILL EXPERIENCING ISSUES WITH THE URINE TAKING TOO LONG TO DRAIN. ALSO STATED THAT THERE WERE SMALL HOLES IN THE CATHETER AS PER CUSTOMER CLARIFICATION VIA PHONE ON 18JAN2023, CUSTOMER STATED THAT THE HOLES IN THE CATHETER WERE WHERE THEY WERE SUPPOSED TO BE, BUT THEY WERE TOO SMALL AND CAUSED URINE BACKUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997413 ↗