Magic3 Go Male Coude Catheter with SureGrip 50816GRecalls & reported problems

Summary

The FDA's MAUDE database contains 239 adverse event reports that list this exact device (DI 00801741137037), received between Jun 18, 2018 and Aug 26, 2026 — classified as 77 injuries, 162 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (46 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 239 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459882 ↗
• MalfunctionMay 1, 2026Disconnection

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS HAVE DETACHED HANDLES AND DEFORMED. THEY DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25060131 ↗
• MalfunctionMay 1, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS HAVE DETACHED HANDLES AND DEFORMED. THEY DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059121 ↗
• MalfunctionFeb 23, 2026Component Missing; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT ADVISED WHEN HE FIRST OPENED THE CATH HE NOTICED THERE WERE NO EYELET HOLES WHERE THE URINE GETS DRAINED FROM THE BLADDER. PT DID REQUEST A WHOLE NEW ORDER BE SENT AND PROVIDED THE LOT NUMBER: JUKX9581, FOR THE PRODUCT. HE DID ASK THAT A DIFFERENT LOT NUMBER BE SENT TO HIM. SENDING OUT REPLACEMENT. PATIENT DID NOT SPECIFY THE NUMBER OF CATHETERS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422020 ↗
• MalfunctionFeb 19, 2026Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THE TIP WAS STILL TOO SHARP. 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 24388782 ↗
• InjuryJan 30, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT ASKED TO GO DOWN A FR SIZE DUE TO DISCOMFORT AND BLEEDING. THE PATIENT HAS SEEN HIS DOCTOR AND THE DOCTOR HAS RECOMMENDED HIM TO GO DOWN TO A 14 FR (NO UTI) THE PATIENT DOESN'T BELIEVE THE BLEEDING WAS CAUSED BY AN ISSUE WITH THE PRODUCT. HE AND HIS DOCTOR THINK HE JUST NEEDS TO START USING A SMALLER SIZE. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PU/EX WAS PUT IN.

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

  MAUDE report 24228777 ↗
• InjuryJan 26, 2026Difficult to Insert; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HARD TIME GETTING CATHETERS BY PROSTATE 7 TIMES. PATIENT PUSHED THROUGH TO BLADDER AND PUNCTURED SOMETHING AND HAD A LITTLE BLOOD FOR SEVERAL DAYS WHICH TURNED INTO ALL BLOOD IN URINE AT 6PM THEN 10PM MORE BLOOD, 2AM MORE BLOOD, 6AM MORE BLOOD YET. HE STILL HAD BLOOD THE LAST 5 TIMES HE CATHED. PATIENT CALLED AMBULANCE THAT MORNING, TOOK PATIENT TO HOSPITAL, HOSPITAL STAY OF 5 DAYS. PATIENT NOW HAS FOLEY FOR THE TIME BEING. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 24185757 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD MANY UTIS. IT IS UNCLEAR IF THE CATHETERS CAUSED THESE UTIS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24063337 ↗
• InjuryDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CEASED CATHETER USE DUE TO UTIS. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 23865681 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DEALING WITH UTI THAT LED TO SEPSIS. HIS CONCERN IS THAT IT HAPPENED DUE TO CATHING AND HE WOULD LIKE TO CLEAR UP ISSUE FIRST BEFORE PLACING ORDER. NO MEDICAL INTERVENTION WAS REPORTED, NO ADDITIONAL INFORMATION PROVIDED. SPOKE WITH CUSTOMER'S AUTHORIZED SPOUSE. IT WAS REPORTED THAT CUSTOMER HAS HAD 4 UTI'S SINCE HE STARTED USING THE CATHETERS. ON SEP 8TH THE CUSTOMER WAS SENT TO A REHAB FACILITY TO TREAT HIS SEPSIS STEMMING FROM THE RECURRENT UTI'S. IT IS UNCONFIRMED WHETHER THE CATHETERS CAUSED THE UTI'S. LOT NUMBER WAS UNAVAILABLE AT THE MOMENT BUT SHE PLANS TO CALL BACK WITH LOT INFO.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 23210897 ↗
• MalfunctionSep 18, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID THERE WAS NO GLUE ON STICKY PART WHEN YOU GO TO DISPOSE OF IT. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085102 ↗
• InjurySep 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT SAID THESE CATHETERS CAUSED PAIN AND BLEEDING. THE PATIENT HAD NOT YET RECEIVED MEDICAL INTERVENTION BUT DID PLAN TO CONSULT WITH HIS PHYSICIAN. IT IS UNCLEAR WHETHER THE LOT NUMBER WAS REQUESTED. LMS DID NOT HAVE AN EMAIL ADDRESS ON FILE FOR THIS PATIENT.

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

  MAUDE report 22963659 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  PT SAID THE CURVED TIP IS CAUSING BLOOD IN HIS URINE. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 28JUL2025 AND IT WAS REPORTED THAT HE VISITED THE DOCTOR AND WAS DIAGNOSED WITH A UTI. CUSTOMER DID NOT SPECIFY WHAT TYPE OF MEDICINE WAS PROVIDED TO TREAT THE UTI. CUSTOMER STATED THAT THE CURVED CATHETERS WERE CAUSING HIM TO BLEED AND HE SPOKE WITH HIS DOCTOR SEVERAL TIMES ABOUT SUBMITTING A NEW PRESCRIPTION FOR A DIFFERENT TYPE OF CATHETER. CUSTOMER ALSO SPOKE WITH LIBERATOR AND WAS ADVISED THAT THEY HAVE TO RECEIVE THE NEW PRESCRIPTION DIRECTLY FROM THE DOCTOR BEFORE ANY CHANGES CAN BE MADE. CUSTOMER WAS VERY UPSET AND DISCONNECTED THE CALL.

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

  MAUDE report 22644673 ↗
• MalfunctionJul 22, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATES THAT THE MAGIC 3 GO IS TO LUBRICATED AND CANNOT BE HANDLED DUE TO THE LUBRICANT AND THAT THE COUDE TIP IS TOO SHARP AND UNCOMFORTABLE. PATIENT WANTS THE MANUFACTURER TO KNOW AND FIX THIS. IT IS UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Discomfort

  MAUDE report 22565605 ↗
• MalfunctionJul 22, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT STATES THAT THE MAGIC 3 GO IS TO LUBRICATE AND CANNOT BE HANDLED DUE TO THE LUBRICANT AND THAT THE COUDE TIP IS TOO SHARP AND UNCOMFORTABLE. PATIENT WANTS THE MANUFACTURER TO KNOW AND FIX THIS. IT IS 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 22565552 ↗
• MalfunctionJul 14, 2025Sharp Edges; Sharp Edges

  PATIENT STATED SOME OF THE CATHETERS WERE STICKING OUT LIKE A FISH FIN. HE SAID THESES WOULD HAVE CUT HIM IF HE HADN'T CAUGHT IT. \ UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED.\ NO ADDITIONAL INFORMATION PROVIDED.\ PATIENT EMAIL ADDRESS:\ NO EMAIL ON FILE PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 29JUL2025, IT WAS REPORTED THAT THE CATHETER DOES NOT HAVE ENOUGH LUBRICANT AND THERE WAS AN AREA ON THE CATHETER THAT SEEMED TO BE SHARP. CUSTOMER DESCRIBED THE AREA AS SHARP LIKE A FISH FIN. SAMPLE AVAILABLE. PENDING SAMPLE RETURN. NO LOT NUMBER WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22493972 ↗
• MalfunctionJun 25, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PT SAID THAT THE MAGIC3 GO CATHETERS ARE NOT LUBRICATED ENOUGH RESULTING DIFFICULT TO INSERT FOR THE PATIENT. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331391 ↗
• MalfunctionJun 25, 2025Improper Chemical Reaction; Improper Chemical Reaction

  PATIENT SAID SOME ARE NOT AS LUBRICATED AS OTHERS. LOT NUMBER WILL NOT BE PROVIDED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA PHONE ON 23JUNE2025, IT WAS REPORTED THAT HE THREW THE NON-LUBRICATED CATHETERS AWAY AND HAS NO LOT NUMBERS. NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22327990 ↗
• MalfunctionJun 20, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT PATIENT SAID THE TIP OF THE INTERMITTENT CATHETER WAS NOT MADE PROPERLY AND IT WAS TOO SHARP AND CAUSED THEM A LOT OF IRRITATION. IT WAS UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 22298651 ↗
• MalfunctionJun 9, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE LUBRICANT ON THE INTERMITTENT CATHETER WAS VERY GREASY AND THICK NOT THIN. DIRECT CONSUMER AND HAD SAMPLES TO RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166803 ↗
• MalfunctionMay 5, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED BY THE PATIENT THAT EVERY 3RD CATHETER WAS DRY, DIDNOT HAVE ENOUGH LUBE ON IT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21959923 ↗
• MalfunctionApr 30, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS AN EXTREME DISCOMFORT WITH INSERTION, SAID THEY ARE TOO FLIMSY, THEY BEND AND TWIST WITH INSERTION, TOO DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934508 ↗
• MalfunctionApr 17, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THEY DO NOT HAVE ENOUGH LUBRICITY. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21856264 ↗
• MalfunctionMar 31, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT SAID THEY ARE TOO HARD TO USE. PATIENT SAID THEY USE TO BE STIFFER, AND HE DOES NOT LIKE THEM, AND THEY DON'T HAVE AS MUCH LUBRICATION. THEY ALSO MADE HIM BLEED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER VIA PHONE ON 19MAR2025, IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETERS WERE TOO SOFT, NOT AS STIFFER AS THE ONES BEFORE THEY WENT ON HOLD, DIFFICULT TO INSERT INTO THE URINARY TRACT, NOT ENOUGH LUBRICATION, MADE HIM BLEED BECAUSE HE PUSHED TOO HARD AGAINST THE PROSTATE DUE TO THE CATHETERS BEING SO SOFT, BUT HE DID NOT HAVE TO SEEK MEDICAL ATTENTION. HE STATED THAT THE CATHETERS NOT THE SAME AND WAS ABLE TO SWITCH TO DIFFERENT CATHETERS THAT HE HAS NO COMPLAINTS ABOUT.

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

  MAUDE report 21731133 ↗
• MalfunctionMar 28, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETERS WERE NOT LUBRICATED ENOUGH FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719107 ↗