Magic3 Go Male Catheter with SureGrip 53814GRecalls & reported problems

Summary

The FDA's MAUDE database contains 490 adverse event reports that list this exact device (DI 00801741136962), received between May 23, 2018 and Dec 15, 2025 — classified as 114 injuries, 376 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (105 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 490 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT STATED HE PUNCTURED A BLOOD VESSEL IN HIS BLADDER WITH THE STUPID CATHETERS AND HAS BLEED SO MUCH THAT HE'S NOW IN THE HOSPITAL WITH ANEMIA. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 23811357 ↗
• MalfunctionDec 10, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE PATIENT SAID THAT IT LOOKS LIKE THE MACHINE CRIMPS THE SIDE OF PACKAGE AND CUTS A HOLE IN IT AND NOT STERILE AND SET THEM ASIDE AND THROWS AWAY BECAUSE NOT STERILE. THE ONES HE GOT ORIGINALLY WERE IN A GREEN PACKAGE HE LIKED THE PACKAGE BETTER. WE SPOKE ABOUT THE CATHETERS AND THE ONES HE USED TO GET IN THE GREEN PACKAGE HE LIKED THE PACKAGE BETTER BECAUSE IT WOULD HANG/ATTACH TO THE WALL OR DOOR AND HE SAID THEY WERE THE MAGIC GO. I TOLD HIM THEY DID REDESIGN THE CATHETERS SO MAYBE IT IS A CHANGE IN PACKAGING. LET PT KNOW IF HE HAS ANY MORE TROUBLE WITH MESSED UP OR OPENED CATHETERS TO PLEASE CB AND WE WOULD REPLACE THEM AND NEED TO GET THE LOT# OFF THE PACKAGE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23771533 ↗
• MalfunctionSep 10, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT SAID THAT HE DEFINITELY RECEIVED 14 FR VERIFIED IT BUT HE SAYS VISUALLY THEY SEEM LARGER THAN THEY NORMALLY DO AND ALSO BY FEEL- SAYS IT IS CAUSING IRRITATION TO URETHRA. EXCHANGING FOR 12 FR. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23015107 ↗
• MalfunctionAug 18, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID M3 GO MADE HIM BLEED. IT IS UNCLEAR IF LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. (FEMALE WICKS USED) PER FOLLOW UP INFORMATION RECEIVED VIA PHONE ON (B)(6) 2025, IT WAS REPORTED THAT THE CUSTOMER USED TWO CATHETERS. CUSTOMER STATED THAT THE FIRST ONE WAS VERY DRY AND SO DECIDED TO TRY ANOTHER ONE. CUSTOMER STATED THAT THERE WAS BARELY ANY LUBRICATE. CUSTOMER STATED THAT HE PROCEEDED TO TRY TO INSERT THE CATHETER AND IN DOING SO IT CAUSED BLEEDING. CUSTOMER STATED THAT HE REACHED OUT TO HIS UROLOGIST TO MENTION BUT DID NOT HAVE TO SEEK ANY ADDITIONAL INTERVENTION. CUSTOMER STOPPED USE AND SWITCHED TO A DIFFERENT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 22828105 ↗
• MalfunctionAug 4, 2025Improper Chemical Reaction; Improper Chemical Reaction

  PATIENT SAID THEY ARE NOT LUBED ENOUGH. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699869 ↗
• MalfunctionJul 31, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT RECEIVED INCORRECT CATHETERS, AND THEY CAUSED BLEEDING, PAINFUL INSERTION AND WITHDRAWAL. TROUBLESHOOTING WAS NOT PERFORMED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED.

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

  MAUDE report 22676001 ↗
• MalfunctionJul 3, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THE PATIENT STATED THE 14FR CATHETERS ARE CAUSING PAIN FEELS TOO BIG. DID A PICKUP AND EXCHANGE FOR THE SMALLER CATHETERS. NO MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Pain

  MAUDE report 22394988 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT BAD URINARY TRACT INFECTION. THE AMBULANCE HAD TO CAME GOT THEM AND PASSED OUT. THEY THINK IT WAS FROM INTERMITTENT CATHETER. THEY WAS NOW IN A NURSING HOME. THEY SAID PATIENT WOULD NOT CATHETERIZE ANYMORE, THEY WAS DONE AFTER URINARY TRACT INFECTION PROBLEM.

  Patient problems: Urinary Tract Infection

  MAUDE report 22338229 ↗
• MalfunctionJun 24, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT NOT ENOUGH LUBRICATION IN INTERMITTENT CATHETER AND PATIENT EXPERIENCED DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 22319992 ↗
• MalfunctionJun 13, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT 1 BOX OF INTERMITTENT CATHETERS WERE NOT LUBRICATED PROPERLY. ALL THE OTHERS WERE LUBRICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202353 ↗
• MalfunctionJun 12, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THE BOX OF INTERMITTENT CATHETER ARE DRY AND UNCOMFORTABLE TO USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 22194606 ↗
• MalfunctionMay 9, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PT SAID SOME ARE NOT LUBED AND OPEN THE PACKAGING IS HARDER TO OPEN NOT LIKE OLD M3GO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993816 ↗
• MalfunctionMay 5, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS CAUSE BLEEDING SOMETIMES. PATIENT ALSO STATED THAT THE SLEEVE SLIDES OFF TOO EASILY AND SOMETIMES FALLS OFF ONTO THE FLOOR. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON 16APR2025, IT WAS REPORTED THAT THE GREEN SLEEVE SLIDES DOWN AN SEEMED TOO LOOSE. MILLIMETERS BETWEEN SLEEVE AND CATHETER SHOULD HAVE BEEN SNUGGER. THEY STATED THAT WHEN PATIENT HAD THE BLEEDING PATIENT DID NOT DO ANYTHING DIFFERENT. THEY STATED THAT PATIENT APPLIED THE CATHETER SLOW AND IT SEEMED LIKE IT GOT SUCK. PATIENT SAID IT HAPPENED ABOUT 3 TIMES. PATIENT SUGGESTED THAT THE END OF THE CATHETERS BE MORE ROUNDED OFF(SMOOTHER) INSTEAD OF POINTY. NO SAMPLE. THEY WILL CHECK TO SEE IF THEY HAVE A LOT AND CALL BACK.

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

  MAUDE report 21959926 ↗
• MalfunctionApr 8, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE NOT LUBRICATED. IT WAS NOTED THAT THE GIVEN LOT#: JUJX0201

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21797795 ↗
• InjuryMar 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SOME BLEEDING, MAY NEED A SMALLER SIZE. IT WAS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW UP VIA PHONE ON 25MAR2025, IT WAS REPORTED THAT THE STRAIGHT TIP CATHETER MADE PATIENT BLEED. PATIENT DOCTOR SWITCHED THEM TO COUDE CATHETERS AND THERE WAS MORE BLEEDING. PATIENT DID SEEK MEDICAL ATTENTION AND WAS PUT ON A MALE EXTERNAL CATHETER UNTIL THEY HEALED AND COULD RESUME USE OF THE INTERMITTENT CATHETER.

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

  MAUDE report 21719618 ↗
• MalfunctionMar 26, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS NOT ENOUGH LUBRICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21696645 ↗
• MalfunctionMar 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT WAS CALLING BACK WITH THE LOT NUMBER OF 6 DEFECTIVE MAGIC 3 THAT HAD NO HOLES IN THEM (LOT # JUJW0191).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21688465 ↗
• MalfunctionMar 25, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE END IS TOO SHARP (POKE CUSTOMER) MAKES HIM BLEED NOT ROUNDED ENOUGH TOO SKINNY HAVE TO HOLD-REP PROCESSED /EXCHANGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21688458 ↗
• MalfunctionMar 20, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT ADVISED CATHETERS WERE NOT LUBRICATED ENOUGH, FELT ROUGH AND OPENING WAS NOT LARGE ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21653610 ↗
• MalfunctionMar 20, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT ADVISED CATHETERS WAS NOT LUBRICATED ENOUGH/FELT ROUGH/OPENING NOT LARGE ENOUGH. PATIENT EMAIL ADDRESS: (B)(6). (CASE #(B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652700 ↗
• MalfunctionMar 11, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE WHEN THE PATIENT OPENED THE CATHETERS, IT WAS COMPLETELY DRY. THERE WAS NO LUBRICANT ON THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574479 ↗
• MalfunctionMar 11, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT PATIENT HAD SEVERAL INTERMITTENT CATHETERS THAT DID NOT HAVE ANY FLUID HOLES AT THE END. PATIENT SAID ADDITIONALLY THE URINE EXIT HOLES ON THESE CATHETERS WERE TOO SMALL AND THAT NOT ALL THE HOLES AT THE END HAVE BEEN THE SAME SIZE. PATIENT SAID IT WAS EASY TO TELL BECAUSE THE FLUID VOLUME AND SPEED AT WHICH THE FLUID EXITS WAS SLOWER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21572169 ↗
• MalfunctionFeb 26, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THERE WAS NO LUBRICANT ON THE MALE INTERMITTENT CATHETER. THE PATIENT SAID IT WAS DIFFICULT TO USE AND FOUND IT DIFFICULT TO REMOVE. PATIENT ALSO REPORTED THAT EACH PACKET WAS FLAT SINCE THERE WAS NO LUBRICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21469456 ↗
• MalfunctionFeb 20, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE INTERMITTENT CATHETERS WERE DEFECTIVE, GREY AND THE LUBRICANT WAS DRIED UP. PATIENT ALSO STATED THAT THE CATHETERS WERE IMPROPERLY SEALED. THEY CAUSED PATIENT BLEEDING AND PAIN AND WERE DIFFICULT TO INSERT. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 21421469 ↗
• MalfunctionFeb 14, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT SAID INTERMITTENT CATHETERS WERE TERRIBLE, NOT ENOUGH LUBE AND PAINFUL INSERTION.

  Patient problems: Pain

  MAUDE report 21383896 ↗