Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50610Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741068065), received between Oct 24, 2018 and Dec 3, 2021 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Nonstandard Device” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE MAGIC3 INTERMITTENT CATHETERS WERE MISSING THE WATER PACKET. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS.

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

  MAUDE report 12926010 ↗
• MalfunctionSep 17, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT WAS A MINOR AND ASKED FOR ADDITIONAL LUBRICANT PACKETS BECAUSE THE PATIENT WAS LEARNING TO USE THE MAGIC 3 INTERMITTENT CATHETER. IT WAS ALSO STATED THAT BY THE TIME WHEN THE PATIENT GETS READY TO INSERT THE CATHETER IT WAS DRYING UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12487422 ↗
• MalfunctionJun 11, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS TOO BIG AND CAUSED BLEEDING AND DISCOMFORT.

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

  MAUDE report 11987410 ↗
• MalfunctionNov 9, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE PATIENT HAD AROUND 20 OUT OF THE BOX THAT WERE DAMAGED AND COULD NOT BE USED AND THEY WERE BENT ALL DIFFERENT WAYS AND COULD NOT USE THEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10812159 ↗
• MalfunctionJul 10, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CATHETER WAS TOO FLIMSY AND PATIENT ALSO FELT SEDIMENT GETTING CAUGHT IN COUDE TIP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259596 ↗
• MalfunctionJun 16, 2020Partial Blockage; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH BLOCKAGES FORMING IN THE INTERMITTENT CATHETER AND RESTRICTING THE URINE TO PASS THROUGH EASILY.

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

  MAUDE report 10157680 ↗
• MalfunctionMay 14, 2020Nonstandard Device; Nonstandard Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE TIP OF THE COUDE WAS BENT MORE THAN NORMAL AND THE PATIENT THREW IT OUT AND GOT ANOTHER. ALSO STATED THAT THIS HAPPENED A COUPLE OF TIMES.

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

  MAUDE report 10055917 ↗
• MalfunctionJul 30, 2019Difficult to Insert; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS DIFFICULT TO INSERT. THE PATIENT WAS ABLE TO INSERT THE CATHETER BUT WAS UNABLE TO VOID DUE TO THE CATHETER SLIDING BACK OUT, AND NOT STAYING IN LONG ENOUGH TO DRAIN THE BLADDER.

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

  MAUDE report 8841084 ↗
• MalfunctionJul 29, 2019Nonstandard Device; Nonstandard Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER SLID BACK OUT AFTER INSERTION, NOT STAYING IN LONG ENOUGH TO DRAIN THE BLADDER.

  Patient problems: No Consequences Or Impact To Patient; Urinary Retention

  MAUDE report 8837398 ↗
• MalfunctionFeb 28, 2019Short Fill; Therapeutic or Diagnostic Output Failure; Short Fill

  IT WAS REPORTED THAT THE WATER SACHET OF THE MAGIC 3 CATHETER WAS COMPLETELY EMPTY.

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

  MAUDE report 8377376 ↗
• MalfunctionJan 7, 2019Nonstandard Device; Defective Device; Nonstandard Device

  IT WAS REPORTED THAT THE MAGIC 3 COUDE CATHETER WAS CURVED MORE THAN USUAL.

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

  MAUDE report 8222836 ↗
• MalfunctionOct 24, 2018Nonstandard Device; Difficult to Insert; Nonstandard Device; Material Integrity Problem

  IT WAS REPORTED THAT THE COUDE TIP OF THE CATHETER WAS CURVED MORE THAN USUAL AND THE PATIENT WAS THEREFORE UNABLE TO INSERT AND USE THE CATHETER. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 7999358 ↗
• MalfunctionOct 24, 2018Product Quality Problem; Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY AND WAS THEREFORE MORE DIFFICULT TO INSERT. THE PATIENT ALLEGEDLY EXPERIENCED SELF-LIMITED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 7999155 ↗