Magic3™ Intermittent Catheter 51312Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741068126), received between Aug 16, 2019 and Nov 1, 2020 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2020Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THERE WERE ABOUT 15 INTERMITTENT FIRM MAGIC CATHETERS IN LAST ORDER THAT WERE BENT/KINKED AND PATIENT WAS UNABLE TO USE THEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10767729 ↗
• MalfunctionFeb 28, 2020Defective Component; Component Missing; Component Missing

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS WERE EITHER "DEFECTIVE", OR MISSING FROM THE PACKAGE.

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

  MAUDE report 9769583 ↗
• MalfunctionOct 24, 2019Device Damaged Prior to Use; Component Missing; Material Split, Cut or Torn; Device Damaged Prior to Use

  IT WAS REPORTED A MAGIC 3 CATHETER WAS CUT ON THE OUT FLOW SIDE. THE PATIENT INSERTED A URINARY CATHETER AND WHEN REMOVED, DISCOVERED THAT THE END WAS MISSING.

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

  MAUDE report 9233337 ↗
• InjuryOct 23, 2019Break; Component Missing; Material Split, Cut or Torn; Break

  IT WAS REPORTED A MAGIC 3 CATHETER WAS CUT DIAGONALLY ON THE INFLOW SIDE. THE PATIENT INSERTED A URINARY CATHETER AND WHEN REMOVED, DISCOVERED THAT THE END WAS MISSING. A BLADDER ENDOSCOPE WAS PERFORMED TO SEE IF THE MISSING PIECE WAS IN THE BLADDER OR EMBEDDED IN THE WALL OF THE BLADDER. PRESCRIBING CLINIC STARTED UTI TREATMENT. PER PATIENT, THE UTI MAY OR MAY NOT BE RELATED TO THIS EVENT. PATIENT ALSO REPORTED THAT ANOTHER CATHETER WAS FOUND WITH A DIAGONAL CUT ON THE OUT FLOW SIDE OF THE URINARY CATHETER.

  Patient problems: Injury; No Known Impact Or Consequence To Patient; Urinary Tract Infection

  MAUDE report 9226750 ↗
• MalfunctionOct 11, 2019Break; Component Missing; Break

  IT WAS REPORTED THAT THE TIP WAS MISSING FROM THE MAGIC 3 CATHETER.

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

  MAUDE report 9179525 ↗
• MalfunctionOct 11, 2019Break; Break

  IT WAS REPORTED THAT THE TIP WAS MISSING FROM THE MAGIC 3 CATHETER. THE PATIENT REPORTEDLY NOTICED THE TIP WAS MISSING AFTER THE CATHETER WAS USED. THE PATIENT REPORTEDLY WENT TO THE DOCTOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9179440 ↗
• MalfunctionAug 16, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS POINTED AND SHARP AND WAS NOT POLISHED OR ROUND WHICH ALLEGEDLY CAUSED THE PATIENT TO EXPERIENCED SELF-LIMITED BLEEDING DURING USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8903648 ↗
• MalfunctionAug 16, 2019Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER ONLY MEASURED 4 INCHES BUT WAS SUPPOSED TO MEASURE 6 INCHES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903228 ↗