Magic3 Go Male Catheter with SureGrip 53818GRecalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741136986), received between May 24, 2018 and Jun 18, 2025 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (9 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PATIENT SAID THAT THE INTERMITTENT CATHETERS WERE TOO LARGE AND THEY WERE CAUSED PATIENT BLADDER TO SPASM. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 22285826 ↗
• MalfunctionFeb 13, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THESE MAGIC 3 GO MALE CATHETERS WERE TOO LIMP AND SOME WERE DRYER THAN USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16363735 ↗
• InjuryJan 13, 2023Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT TRIED A SAMPLE OF THIS INTERMITTENT CATHETER BUT THE PATIENT WAS UNABLE TO GET THE INTERMITTENT CATHETER INSERTED. THE PATIENT ALSO STATED THAT THEY HAD SOME SCAR TISSUE IN THEIR URETHRA. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Scar Tissue

  MAUDE report 16156802 ↗
• MalfunctionJan 31, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MALE INTERMITTENT CATHETERS WERE NOT LUBRICATED ENOUGH, SO THE PATIENT HAD TO ADD THEIR OWN LUBRICANT. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13401850 ↗
• MalfunctionDec 10, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE TOP OF THE INTERMITTENT CATHETER BROKE AND SLIDE DONE ON THE CATHETER. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS PRODUCT LESS THAN 90 DAYS AND IT WAS MENTIONED AS OUT OF BOX FAILURE. PER EMAIL FROM LIBERATOR ON 04JAN2022, THE TOP OF THE CATHETER WAS BROKE AND PART OF IT DOWN AT THE BOTTOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12981414 ↗
• MalfunctionSep 7, 2021Difficult to Insert; Inadequacy of Device Shape and/or Size; Difficult to Insert; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT HAD SCAR TISSUE IN THE URETHRA AND FINDS IT DIFFICULT TO INSERT THE MAGIC3 GO MALE CATHETER. PATIENT THOUGHT THE CATHETER WAS RECEIVING HAD THE SURE GRIP BECAUSE THEY WOULD NOT BE ABLE TO USE IT WITHOUT THE GRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12432896 ↗
• InjuryJun 11, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION AND USED UP TO 4X DAY. THE PATIENT WAS WORKING WITH DOCTOR TO SEE IF NEEDED THESE MAGIC 3 CATHETERS. IT IS UNKNOWN IF THE DEVICE CAUSED URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 11987649 ↗
• MalfunctionJan 7, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT FELT DIFFICULT TO INSERT THE CATHETERS, WHICH RESULTED IN A HOSPITAL VISIT AND PATIENT WAS TEMPORARILY ON A FOLEY CATHETER. LIBERATOR REPRESENTATIVE WAS WORKING ON OBTAINING A NEW PRESCRIPTION FROM THE DOCTOR.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Code Available

  MAUDE report 11135794 ↗
• MalfunctionJan 5, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT PATIENT FELT THAT THE MAGIC 3 GO SEEMED BIGGER IN DIAMETER VS THE MAGIC 3 HYDRO.

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

  MAUDE report 11119415 ↗
• MalfunctionSep 15, 2020Improper Chemical Reaction; Manufacturing, Packaging or Shipping Problem; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO INTERMITTENT CATHETERS WERE UNCOMFORTABLE AND THE PATIENT FELT THEY DID NOT HAD ENOUGH LUBRICATION. IT WAS ALSO STATED THAT THE PATIENT STILL FELT THE DISCOMFORT HOURS AFTER USE.

  Patient problems: Discomfort

  MAUDE report 10536618 ↗
• MalfunctionAug 12, 2020Component Missing; Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT TWO OF THE MAGIC 3 GO MALE INTERMITTENT CATHETERS HAD NO EYELETS.

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

  MAUDE report 10398595 ↗
• InjuryApr 21, 2020Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility

  IT WAS REPORTED THAT THE PATIENTS WIFE SAID THE PATIENT HAD A URINARY TRACT INFECTION AND WENT TO THE EMERGENCY ROOM; SHE SAID SHE DID NOT KNOW WHETHER IT WAS THE CATHETER THAT CAUSED THE URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 9980746 ↗
• MalfunctionApr 9, 2020Material Perforation; Output Problem; Material Perforation

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE NOT WORKING.

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

  MAUDE report 9945344 ↗
• MalfunctionMar 10, 2020Product Quality Problem; Component Missing; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY.

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

  MAUDE report 9813967 ↗
• MalfunctionSep 12, 2019Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 GO CATHETER WAS NOT PRE-LUBRICATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9012323 ↗
• MalfunctionJul 17, 2019Product Quality Problem; Product Quality Problem; Defective Component

  IT WAS REPORTED THAT THE LUBRICANT WAS DRIED OUT. THE PATIENT HAD TO RUN THE CATHETER UNDER HOT WATER IN ORDER TO FULLY INSERT IT FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 8799153 ↗
• MalfunctionJul 8, 2019Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY. NO PATIENT INJURY REPORTED.

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

  MAUDE report 8768973 ↗
• MalfunctionJun 13, 2019Device Damaged Prior to Use; Device Damaged Prior to Use; Material Deformation

  IT WAS REPORTED THAT 3 OR 4 OF THE CATHETERS HAD A TINY BUMP ON THE TUBE OF THE CATHETERS AND THE PATIENT URETER WAS SCRATCHED AND CAUSED SELF LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 8695939 ↗
• MalfunctionMay 14, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY. NO PATIENT INJURY REPORTED.

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

  MAUDE report 8608120 ↗
• MalfunctionApr 9, 2019Misassembled; Component Missing; Misassembled

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER DID NOT HAVE ANY EYELETS.

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

  MAUDE report 8497733 ↗
• MalfunctionFeb 4, 2019Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED SOME SELF LIMITED BLEEDING DURING THE INSERTION OF THE CATHETER. THE PATIENT WAS NOT ABLE TO FULLY INSERT THE CATHETER FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8301303 ↗
• MalfunctionAug 29, 2018Product Quality Problem; Appropriate Device Problem Term/Code Not Available; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS DID NOT HAVE ENOUGH LUBRICATION; SO THE PATIENT ADDED KY JELLY TO THE CATHETERS TO BE ABLE TO INSERT AND USE THEM.

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

  MAUDE report 7829233 ↗
• MalfunctionAug 27, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICATION.

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

  MAUDE report 7817267 ↗
• InjuryJul 24, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION WHILE USING THE CATHETER. IT IS UNKNOWN IF MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT DECLINED TO GIVE ANY ADDITIONAL INFORMATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 7713461 ↗
• MalfunctionMay 29, 2018Product Quality Problem; Material Integrity Problem; Product Quality Problem

  IT WAS REPORTED THAT THE HYDROPHILIC COATING ON THE MAGIC 3 CATHETERS WERE UNEVEN. THE COATING ALLEGEDLY CLUMPS IN ONE SPOT, FELT SLIMY AND LACKED LUBRICITY IN OTHER AREAS. THE PATIENT ALLEGEDLY EXPERIENCED IRRITATION OF HIS URETHRA, PAIN, AND SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Irritation; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 7550083 ↗