Magic3™ Intermittent Catheter 53312Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741068416), received between Nov 12, 2017 and May 15, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2019Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO INSERT THE CATHETERS DUE TO PAIN AND DISCOMFORT WITH USE. NO MEDICAL INTERVENTION AS REQUIRED.

  Patient problems: Discomfort; Pain

  MAUDE report 8613590 ↗
• MalfunctionFeb 5, 2019Incorrect Measurement; Appropriate Device Problem Term/Code Not Available; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER FAILED THE DIMENSIONAL ANALYSIS EVALUATION. FDA CUSTOMS DETAINED THIS PRODUCT AT THE BORDER WHERE IT WAS RANDOMLY SELECTED TO BE SAMPLED AND SENT TO AN FDA SELECTED LABORATORY FOR INSPECTION.

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

  MAUDE report 8304707 ↗
• MalfunctionJan 22, 2019Break; Tear, Rip or Hole in Device Packaging; Material Integrity Problem; Packaging Problem; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE END OF THE CATHETER APPEARED TO BE CUT OFF AND LEFT THE SHARP EDGE POKING OUT OF THE PACKAGE.

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

  MAUDE report 8267531 ↗
• MalfunctionJan 22, 2019Incorrect Measurement; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE DIAMETER OF THE MAGIC 3 CATHETERS VARY IN SIZE. COMPLAINANT ALLEGEDLY EXPERIENCED SELF-LIMITED BLEEDING WITH THE USE OF SOME OF THE CATHETERS DUE TO THE VARYING DIAMETERS.

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

  MAUDE report 8267476 ↗
• MalfunctionNov 21, 2018Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT FOUND THE CATHETER WAS A DIFFERENT SIZE THAN A 12FR. WHEN THE DEVICE WAS REMOVED THERE WAS SELF LIMITED BLEEDING AND WAS NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 8097016 ↗
• MalfunctionNov 21, 2018Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT EACH CATHETER HAS A DIFFERENT SIZE.

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

  MAUDE report 8097015 ↗
• MalfunctionOct 30, 2018Incorrect Measurement; Incorrect Measurement; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER DIAMETER CHANGED AS IT GOT TO THE TIP.

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

  MAUDE report 8021400 ↗
• MalfunctionOct 22, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS LISTED AS 12FR ON THE PACKAGING, HOWEVER IT WAS NOTED THAT THE DIAMETER DECREASED OVER THE LENGTH OF THE CATHETER. THE PATIENT ALLEGEDLY EXPERIENCED SELF LIMITED BLEEDING AND DISCOMFORT DURING THE INSERTION OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort; Patient Problem/Medical Problem

  MAUDE report 7993759 ↗
• MalfunctionOct 10, 2018Incorrect Measurement; Difficult to Insert; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER WAS NOT EVENLY SIZED. IT WAS THICKER AT SOME POINTS; THEREFORE, THE PATIENT EXPERIENCED SOME DIFFICULTY INSERTING THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7953704 ↗
• MalfunctionNov 12, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS TOO NARROW. THE PATIENT EXPERIENCED SELF-LIMITED BLEEDING AND IRRITATION. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Irritation

  MAUDE report 7023778 ↗