Magic3 Go Male Coude Catheter with SureGrip 50814GRecalls & reported problems

Summary

The FDA's MAUDE database contains 416 adverse event reports that list this exact device (DI 00801741137020), received between May 24, 2018 and Sep 10, 2026 — classified as 3 deaths, 109 injuries, 304 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (85 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 416 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716254 ↗
• MalfunctionMar 30, 2026Component Misassembled

  IT WAS REPORTED THAT PER PATIENT WIFE, JUST WANTED TO LET US KNOW SHE HAS NEVER SEEN ANYTHING LIKE THIS BEFORE AND HER HUSBAND HAS BEEN USING CATHETERS FOR YEARS. SHE FOUND 1 WITHOUT HOLES AND WAS WONDERING WHY IT WAS NOT WORKING. WHEN SHE TOOK IT OUT SHE NOTICED THAT IT DID NOT HAVE THE HOLES IN IT. SHE DOES NOT THINK IT WORTH SENDING 1 REPLACEMENT JUST WANTED TO LET US KNOW AND HAVE IT DOCUMENTED. PATIENT HAS ORDERED THIS PRODUCT PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24715461 ↗
• MalfunctionMar 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT PT STATED SEVEN OF THE CATHS WERE FAULTY AND WOULD BEND WHENEVER HE WOULD TRY TO INSERT THEM. SET UP A PICKUP AND EXCHANGE. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483775 ↗
• MalfunctionFeb 18, 2026Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS CAUSED "TRAUMA" AS THE CURVE WAS SHARP. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED OR LOT NUMBER REQUESTED. NO MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 24378472 ↗
• MalfunctionDec 24, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PT STATED THAT THE SLIGHTING COMPONENT ON CATH IS TOO LOOSE. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890473 ↗
• InjuryDec 11, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT SAID HE ENDED UP IN THE HOSPITAL WHEN USING THESE CATHETERS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 23777938 ↗
• InjuryOct 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT SAID THAT HE GOT SCRAPED THEN HE WOULD GET UTI'S BUT DON'T KNOW IF RELATED. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Abrasion; Urinary Tract Infection

  MAUDE report 23199769 ↗
• MalfunctionSep 29, 2025Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE MAGIC 3 GO WAS NOT DRAINING THE BLADDER. REPRESENTATIVE CHOSE DIFFERENT AND PROCESSED PU/EX TO SHIP REFERRED CATHETER. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW UP INFORMATION RECEIVED FROM CUSTOMER VIA PHONE ON 03DEC2025, IT WAS REPORTED THAT HE EXPERIENCED LEAKING WITH THE MAGIC 3 CATHETER GO CATHETER. CUSTOMER HAS SWITCHED TO ANOTHER TYPE OF CATHETER, AND NO FURTHER ISSUES WERE REPORTED. CUSTOMER STILL HAS A SAMPLE AVAILABLE. REQUESTED ANOTHER SAMPLE RETURN KIT BECAUSE HE NEVER RECEIVED THE FIRST ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23168771 ↗
• MalfunctionSep 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID ABOUT 10 CATHETERS WERE DEFECTIVE AND UNUSABLE AS THE GUIDE INDICATOR WAS FACING THE WRONG DIRECTION. 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 23142551 ↗
• MalfunctionSep 24, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THAT THERE WAS BLEEDING WITH SHARP EDGE AND ALSO SAID PAIN DISCOMFORT. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PER FOLLOW-UP INFORMATION RECEIVED FROM CUSTOMER VIA PHONE ON 04NOV2025. IT WAS REPORTED THAT HE EXPERIENCED BLEEDING WHILE USING THE PRODUCT. THERE WAS NO MEDICAL INTERVENTION REPORTED, AND CUSTOMER DID NOT TREAT THE BLEEDING. HE WAS IMPACTED BECAUSE HE WAS SORE AND STILL HAD TO USE THE CATHETERS. SAMPLE IS AVAILABLE. PENDING SAMPLE RETURN.

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

  MAUDE report 23135236 ↗
• MalfunctionSep 18, 2025Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PATIENT SAID SOME OF THEM SCRAPE AS IF THE EYELETS WERE NOT POLISHED ENOUGH, SOME ARE TOO BENT TO USE. 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 23085505 ↗
• MalfunctionSep 18, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID SOME OF THEM SCRAPE AS IF THE EYELETS WERE NOT POLISHED ENOUGH, SOME ARE TOO BENT TO USE. 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 23085504 ↗
• MalfunctionSep 11, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THE PATIENT SAID THERE IS NOT ENOUGH LUBRICANT ON THE CATHETERS, THEY ARE DRY. 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 23025820 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT PATIENT GOT URINARY TRACT INFECTION MAYBE FROM CATHETERIZING. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23017573 ↗
• MalfunctionJun 30, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS A BUBBLE IN THE TIP OF THE CATHETER THAT OBSTRUCTED THE CATHETER FROM INSERTING TO THE BLADDER. PATIENT ADVISED THAT THE CATHETER CAUSED SEVERE BLEEDING, AND THEY WERE UNABLE TO USE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 22358300 ↗
• MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE PATIENT SAID HE HAD SOME CATHETERS THAT WERE CURVED CAUSING DISCOMFORT. IT DOES NOT HAPPEN WITH EVERY CATHETER, BUT SOME ARE ARRIVING MORE CURVED THAN NORMAL AND CAUSING DISCOMFORT. HE HAS THROWN AWAY 10. SENDING REPLACEMENTS. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Discomfort

  MAUDE report 22336134 ↗
• MalfunctionJun 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE PATIENT SAID IT HURTS TO WITHDRAW THE CATHETER. LOT NUMBER WAS NOT PROVIDED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 22336132 ↗
• MalfunctionJun 20, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CUSTOMER STATED THE INTERMITTENT CATHETERS WERE NOT LUBE ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298689 ↗
• MalfunctionMay 22, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THERE SEEMED TO BE LESS LUBE AND CAUSED HIM A BIT OF PAIN. NO ADDITIONAL INFORMATION PROVIDED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 22069414 ↗
• MalfunctionMay 14, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE PATIENT ATTEMPTED TO INSERT THE INTERMITTENT CATHETERS. THE PATIENT FELT LIKE THEIR SKIN WAS TEARING. THEY GOT ABOUT 1 INCH IN AND WITHDREW THE CATHETER STATES THEY HAD BLEEDING UPON FURTHER CHECKING THERE WAS A PIECE OF MATERIAL WAS STICKING OUT AND MATERIAL CUT THEM. PER CUSTOMER VIA PHONE ON (B)(6) 2025, IT WAS REPORTED THEY RECEIVED THE REPLACEMENT AND SENT DEFECTIVE BACK ALREADY.

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

  MAUDE report 22020426 ↗
• MalfunctionApr 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT PT SAID THAT WHEN THEY WITHDREW THE CATHETER, IT DRAGGED AND STUNG. THEY SAID THE CATHETERS DON'T HAVE ANY INSTRUCTIONS LISTED ON THE PACKAGE TO TELL YOU HOW TO USE THEM. PATIENT EMAIL ADDRESS: (B)(6). (B)(4).

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

  MAUDE report 21785952 ↗
• MalfunctionFeb 28, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THERE WAS NO LUBRICANT ON THE INTERMITTENT CATHETERS RESULTED IN THEM NOT BEEN EASY TO FOLD. PATIENT DID NOT FELT COMFORT USING THEM. PROCESSED PU/EX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21493790 ↗
• MalfunctionFeb 18, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 GO MALE COUDE INTERMITTENT CATHETERS WAS FOLDED IN THEIR POCKET, THEY SAID IT SHRUNK. THEY WOULD NOT BE EASY TO TRAVEL WITH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21392379 ↗
• MalfunctionFeb 14, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE TOO THICK CAUSING THE PATIENT TO BLEED. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 21384120 ↗
• MalfunctionFeb 14, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE NOT LUBRICATED ENOUGH AND WAS RETURNING THESE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21384116 ↗