Magic3™ Intermittent Catheter 53318Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741068447), received between Jan 2, 2019 and Dec 12, 2019 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Misassembled” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2019Component Missing; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT SIX PACKAGES WERE RECEIVED MISSING THE CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 9457262 ↗
• MalfunctionJun 25, 2019Misassembled; Misassembled; Component Missing

  IT WAS REPORTED THAT ONE OF THE CATHETERS DID NOT HAVE EYELETS.

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

  MAUDE report 8731031 ↗
• MalfunctionJan 29, 2019Misassembled; No Flow; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES WERE NOT PUNCHED ON THE CATHETER. AS A RESULT, THE CATHETER WOULD NOT DRAIN AFTER INSERTION. NO PATIENT INJURY WAS REPORTED AND THE CATHETER WAS REPLACED.

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

  MAUDE report 8285959 ↗
• MalfunctionJan 2, 2019Misassembled; Infusion or Flow Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES WERE NOT PUNCHED ON THE CATHETER. AS A RESULT, WHEN THE PATIENT INSERTED THE CATHETER, THE CATHETER WOULD NOT DRAIN. NO PATIENT INJURY WAS REPORTED AND THE CATHETER WAS REPLACED.

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

  MAUDE report 8210099 ↗
• MalfunctionJan 2, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; No Flow; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS A SMALLER FRENCH SIZE. THE FRENCH SIZE WAS ALLEGEDLY 16FR, RATHER THAN THE 18FR. THE MUCUS FROM THE PATIENT WAS UNABLE TO DRAIN THROUGH THE SMALLER FRENCH SIZE. THEREFORE, THE CATHETER WOULD NOT DRAIN AND WAS REPLACED. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 8210094 ↗
• MalfunctionJan 2, 2019Misassembled; Material Integrity Problem; Misassembled

  IT WAS REPORTED THAT THE DRAINAGE EYES WERE NOT PUNCHED ON THE CATHETER. AS A RESULT, WHEN THE PATIENT INSERTED THE CATHETER THE CATHETER WOULD NOT DRAIN. NO PATIENT INJURY WAS REPORTED AND THE CATHETER WAS REPLACED.

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

  MAUDE report 8209630 ↗