Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50618Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741068102), received between Apr 25, 2017 and Jan 16, 2026 — classified as 3 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (9 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 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Component Misassembled

  IT WAS REPORTED THAT THE PATIENT SAID THERE ARE NO HOLES IN THE TIP OF THE CATHETER. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103139 ↗
• MalfunctionJan 14, 2026Material Protrusion/Extrusion

  IT WAS REPORTED THE PATIENT SAID THERE IS NOT ENOUGH LUBRICITY ON SOME CATHETERS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA PHONE 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. PER NOTIFICATION FROM UCC ON 12JAN2026, IT WAS REPORTED THAT FLASH WAS OBSERVED ON CATHETER DURING SAMPLE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24069475 ↗
• MalfunctionSep 22, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT SAID HE HAD TO THROW OUT SOME OF THE CATHETERS BECAUSE THEY WERE BENT AND TWISTED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23110382 ↗
• MalfunctionAug 19, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THERE IS NOT ENOUGH LUBRICITY ON SOME CATHETERS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA PHONE ON (B)(6) 2025, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22839342 ↗
• MalfunctionJun 11, 2025Improper Chemical Reaction; Improper Chemical Reaction

  PATIENT SAID THERE IS NOT ENOUGH LUBRICITY ON SOME CATHETERS. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PER CUSTOMER VIA PHONE 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183878 ↗
• MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 MALE INTERMITTENT CATHETER COULD BE BENT (BADLY), TWISTED OR HAD INSUFFICIENT WATER IN THE SACHETS. PER CUSTOMER VIA PHONE ON 23DEC2024, IT WAS REPORTED THAT 3 TO 4 CATHETERS WERE BENT OR DID NOT HAD ENOUGH LUBRICANT. THEY DID NOTIFY THEIR SUPPLIER, AND THEY REPLACED THE DEFECTIVE CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035451 ↗
• MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE MAGIC 3 MALE INTERMITTENT CATHETER COULD BE BENT (BADLY), TWISTED OR HAD INSUFFICIENT WATER IN THE SATCHELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035177 ↗
• MalfunctionMay 3, 2023Short Fill; Improper Chemical Reaction; Short Fill; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT COME WITH ENOUGH LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860014 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MAGIC 3 COUDE INTERMITTENT CATHETERS WERE CAUSING URINARY TRACT INFECTION TO THE PATIENT. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 15504940 ↗
• MalfunctionAug 30, 2022Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT SO FAR TWO TIMES THE LUBRICATION WAS EMPTY JUST AIR IN INTERMITTENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319525 ↗
• MalfunctionMar 25, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT HAVE ENOUGH LUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13911253 ↗
• MalfunctionDec 22, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC3 INTERMITTENT CATHETER DID NOT HAVE ENOUGH LUBRICANT DUE TO THAT IF THE PATIENT DID NOT PUT KY JELLY ON THE INTERMITTENT CATHETER, AND WHEN THEY PULLED IT OUT, IT BURNED REALLY BAD. THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Burning Sensation

  MAUDE report 13060511 ↗
• MalfunctionJul 27, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE BURST PACKET WAS SMALLER THAN IT USED TO BE AND THE MAGIC3 COUDE MALE INTERMITTENT CATHETER WAS NOT LUBRICATING AS WELL AS IT SHOULD. ALSO STATED THAT IT DID NOT GO EASILY, BECAUSE IT WAS TOO DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12235289 ↗
• MalfunctionJul 26, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE BURST PACKET WAS SMALLER THAN IT USED TO BE. THE CATHETER WAS NOT LUBRICATED ENOUGH AND DID NOT GO IN AS EASY AS IT USED TO, BECAUSE IT WAS FOUND TO BE TOO DRY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12225424 ↗
• MalfunctionJul 26, 2021Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT STATED ONE OF THE INTERMITTENT CATHETERS THAT WERE USED A WEEK AGO SPREAD THE PATIENT¿S URETHRA. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS CATHETER FOR A YEAR. PER FOLLOW UP RECEIVED ON (B)(6) 2021, THE PATIENT STATED THAT THE CATHETER HAD A BURR ON IT THAT THEY DID NOT NOTICE UNTIL THEY INSERTED IT AND FELT THE PAIN. IT WAS ALSO STATED THAT THE PATIENT DID NOT RECEIVE ANY MEDICAL INTERVENTION, THE PATIENT WAS STINGY AND HAD A BURNING SENSATION FOR ABOUT 5 DAYS.

  Patient problems: Burning Sensation; Pain

  MAUDE report 12224216 ↗
• MalfunctionFeb 18, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT 3 BOXES OF 30 REPLACED INTERMITTENT CATHETERS WERE ALSO SEEMED TO BE DRY, AS THEY WERE LACKING THE HYDROPHILIC COATING.

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

  MAUDE report 11345504 ↗
• MalfunctionJan 13, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 GO HYDROPHILIC COUDE INTERMITTENT CATHETERS DID NOT HAVE ENOUGH LUBRICANT LIKE MAGIC 3 GO COUDE INTERMITTENT CATHETERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11164942 ↗
• MalfunctionJun 18, 2020Improper Chemical Reaction; Improper Chemical Reaction; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE CATHETERS DID NOT WORK WELL AND PATIENT STATED THAT THOSE WERE NOT PRE-LUBRICATED WHICH CAUSED MORE PAIN AND DISCOMFORT. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Pain

  MAUDE report 10167661 ↗
• MalfunctionApr 8, 2020Product Quality Problem; Therapeutic or Diagnostic Output Failure; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS WERE NOT LUBRICATED WHEN HE WAS ADVISED THAT THEY WOULD BE LUBRICATED.

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

  MAUDE report 9938148 ↗
• InjuryJan 23, 2020Improper or Incorrect Procedure or Method; Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT SAID HE HAD TO REUSE CATHETERS IN (B)(6) 2018, AND GOT AN E.COLI INFECTION AND WAS HOSPITALIZED.

  Patient problems: Bacterial Infection; Patient Problem/Medical Problem; Unspecified Infection

  MAUDE report 9621473 ↗
• MalfunctionOct 21, 2019Inability to Irrigate; Obstruction of Flow; Inability to Irrigate

  IT WAS REPORTED THAT THE PATIENT STATED THE CATHETERS SOMETIMES CLOG.

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

  MAUDE report 9214948 ↗
• MalfunctionOct 17, 2019Misassembled; Misassembled

  IT WAS REPORTED THAT THE CATHETER WAS MISSING THE EYELETS TO DRAIN URINE FROM BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9203202 ↗
• MalfunctionJul 3, 2019Short Fill; Short Fill

  IT WAS REPORTED THAT THE PATIENT SAID THERE WAS NOT ENOUGH LIQUID IN THE BURST PACKS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8760037 ↗
• MalfunctionJul 3, 2019Product Quality Problem

  IT WAS REPORTED THAT THE SOLUTION FROM THE BURST PACKS WAS NOT LUBRICATING THE CATHETERS ENOUGH. THE PATIENT ADVISED THAT HE NEEDS TO ADD HIS OWN LUBRICANT FOR USE. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 8758529 ↗
• MalfunctionJul 3, 2019Short Fill; Short Fill; Defective Device

  IT WAS REPORTED THAT THERE WAS NOT ENOUGH WATER IN THE BURST PACKS. NO MEDICAL INTERVENTION REPORTED. THE PATIENT ADVISED VIA PHONE ON (B)(6) 2019 THAT HE LOVES THE MAGIC 3 CATHETER, HOWEVER THE LACK OF WATER IN THE BURST PACK CAUSED HIM TO HAVE TO USE AN ADDITIONAL LUBRICANT WHICH DEFEATS THE PURPOSE OF USING THE HYDRO CATHETER IN THE FIRST PLACE. THE PATIENT STATED THAT THE INTRODUCTION OF AN ADDITIONAL CONTENT TO THE CATHETER INCREASED HIS POTENTIAL FOR A URINARY TRACT INFECTION.

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

  MAUDE report 8758007 ↗