Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616Recalls & reported problems

Summary

The FDA's MAUDE database contains 443 adverse event reports that list this exact device (DI 00801741068096), received between Apr 19, 2017 and Aug 28, 2026 — classified as 2 deaths, 68 injuries, 373 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (83 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 443 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Component Misassembled

  It was reported that the customer states that the catheter did not work, openings were not punctured into the catheter, no suction, just one catheter so far in box. Patient has ordered this product previously.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50501979 ↗
• MalfunctionAug 26, 2026Material Twisted/Bent

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452740 ↗
• MalfunctionAug 11, 2026Material Twisted/Bent

  It was reported that the Patient said 12 catheters were defective, the tip was a true 90 degree, and some were at 45-degree angle. No medical intervention or patient impact reported. No additional information provided. Per liberator clarification received on 30JUL2026, patient used 50616.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208706 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT SAID HE TRIED THE SAMPLES WE SENT FOR ABOUT 2 DAYS AND ENDED UP WITH A UTI. HE DOESN'T KNOW IF IT WAS FROM THE PRODUCTS OR IF HE DID SOMETHING, BUT THE ER PUT HIM ON A FOLEY NOW. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 24958728 ↗
• MalfunctionApr 21, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT THE CUSTOMER STATES THAT HE HAD BLACK STUFF INSIDE OF THE CATHETER. THERE ARE NO REPORTS OF IMPACT OR INJURY TO THE PATIENT. PATIENT HAS ORDERED THIS PRODUCT PREVIOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941082 ↗
• MalfunctionJan 16, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER HAD STATED THE MAGIC 3 COUDE INTERMITTENT CATHETER EYELETS WERE SMALLER, CAUSING BLEEDING AND WERE LESS LUBRICATED.

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

  MAUDE report 24101223 ↗
• MalfunctionJan 2, 2026Material Twisted/Bent

  IT WAS REPORTED THAT THE 24 DEFECTIVE CATHETERS THAT WERE BENT WITH BURST STERILE WATER PACKETS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951631 ↗
• MalfunctionDec 29, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID RECEIVED DEFECTIVE CATHETERS THAT WERE BENT WITH BURST STERILE WATER PACKETS. HE TRIED TO USE CATHETERS, BUT IT CAUSED BLEEDING, THE PATIENT IS OUT OF SUPPLIES DUE TO RECEIVING DAMAGED CATHS. HE ADVISED IF THIS ISSUE HAPPENS AGAIN, HE WILL SWITCH DME. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED. PROCESSED PU/EX FOR DEFECTIVE CATHS AND PLACED REORDER FOR 360 ITEM#RH50616.

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

  MAUDE report 23917360 ↗
• MalfunctionDec 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT STATES THAT SEVERAL CATHETERS WERE BENT/TWISTED AND UNUSABLE. 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 23830147 ↗
• MalfunctionDec 3, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS DID NOT FIT WELL. 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 23708908 ↗
• MalfunctionDec 2, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD ABOUT 10 THAT WERE MANGLED. 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 23700468 ↗
• MalfunctionNov 26, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID MAJORITY IN THE BOX WERE UNUSABLE, THEY WERE BENT AND TWISTED. 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 23659850 ↗
• MalfunctionNov 14, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD SEVERAL INTERMITTENT CATHETERS WHERE THE TIPS WERE DEFORMED CAUSED DISCOMFORT DURING INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort

  MAUDE report 23555302 ↗
• MalfunctionOct 22, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT 1 OF THE CATHETERS OUT OF 540 DIDN'T HAVE ANY HOLES IN THE CATHETER, SO HE JUST THREW IT AWAY. 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 23357712 ↗
• MalfunctionOct 20, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PT SAID IN 2 OF THEM NO EYELETS WERE PUNCHED IN THEM. 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 23337610 ↗
• MalfunctionSep 16, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED BY THE PATIENT THAT PATIENT OPENED HIS LAST BOX OF INTERMITTENT CATHETER, AND EACH CATHETER WAS OPENED-PROCESSED PU/EX TO SHIP OUT REPLACEMENT CATHETER. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23063387 ↗
• InjurySep 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF URINARY TRACT INFECTIONS. NO ADDITIONAL INFORMATION PROVIDED. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22978931 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ADVISED HAD SEVERAL UTIS (URINARY TRACT INFECTION) AND DOCTOR TOLD HIM IT IS DUE TO CATHING. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 22383930 ↗
• MalfunctionJun 25, 2025Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT PATIENT SAID THE INTERMITTENT CATHETER COUDE TIP TURNS THE WRONG WAY SOMETIMES. IT WAS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22329815 ↗
• MalfunctionJun 19, 2025Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT CUSTOMER ORDERED A CASE A MONTH AND HAD SURPLUS 10 DAYS AGO, THEY OPENED ONE BOX AND FOUND ALL 30 INTERMITTENT CATHETERS WERE MISSING THE ADHESIVE FOR HOLDING THE BAG UP WHILE TRYING TO DRAIN. OPENED 5 BOXES WITH SAME LOT# AND ALL 5 BOXES WERE MISSING THE ADHESIVE. NOT ABLE TO USE AND CUSTOMER NEEDED THE ADHESIVE TO HELP DRAIN THE BAG. COULD NOT HOLD IT UP AND DRAIN AT THE SAME TIME. CUSTOMER REQUESTED REPLACEMENT FOR ALL CATHETERS MISSING THE DOUBLE ADHESIVE TAB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292971 ↗
• MalfunctionJun 13, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT SEVERAL INTERMITTENT CATHETERS LUBE WAS MORE LIKE JELLY THAN LIQUID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202345 ↗
• MalfunctionMay 22, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT SAID THEY WOULD NOT LUBRICATE RIGHT DURING COVID BUT ISSUE WAS RESOLVED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070321 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT GOT 2 UTI'S IN A ROW. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 22052805 ↗
• MalfunctionMay 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE BENDING WHEN TRY TO USE. SOME SEEM TO BE BIGGER THAN OTHERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22003928 ↗
• MalfunctionApr 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID THAT THE INTERMITTENT CATHETERS WERE BENT AND TWISTED IN BOX. PER CUSTOMER VIA PHONE ON 13MAY2025, IT WAS REPORTED THAT THE CATHETERS WERE BENT AND TWISTED AS IF SOMEONE HAD JAMMED THEM IN THE BOX. THE CUSTOMER DID NOT HAVE A LOT OR SAMPLE BECAUSE THEY DISPOSED OF THE PRODUCT. IT WAS STATED THAT THEY SWITCHED TO A DIFFERENT CATHETER WHICH WAS WORKING WELL FOR THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934187 ↗