Magic3™ Intermittent Catheter 53512Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741068508), received between Jun 19, 2017 and Feb 19, 2019 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Difficult to Insert” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2019Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE WIFE OF THE PATIENT BELIEVED THAT THIS SPECIFIC LOT OF CATHETERS CAUSED A URINARY TRACT INFECTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Urinary Tract Infection

  MAUDE report 8351762 ↗
• MalfunctionJan 23, 2019Product Quality Problem; Material Deformation; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS DRY.

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

  MAUDE report 8270093 ↗
• MalfunctionOct 29, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETERS HAD VARYING DIAMETERS. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8016289 ↗
• MalfunctionSep 25, 2018Incorrect Measurement; Material Integrity Problem; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS THAT THE PATIENT RECEIVED, HAVE DIFFERENT DIAMETERS IN THICKNESS. THE THICK ONES HAVE CAUSED PAIN UPON INSERTION. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Pain

  MAUDE report 7906652 ↗
• MalfunctionMay 31, 2018Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT NOT ALL OF THE MAGIC 3 CATHETERS RECEIVED ARE THE SAME WIDTH. THE PATIENT REPORTED EXPERIENCING PAIN WHILE USING THE CATHETERS THAT ALLEGEDLY HAVE LARGER DIAMETERS THAN THE OTHERS.

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

  MAUDE report 7558421 ↗
• MalfunctionSep 6, 2017Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CATHETER APPEARED TO BE LARGER THAN NORMAL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6845998 ↗
• MalfunctionJul 17, 2017Difficult to Insert; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS NOT LUBRICATED AND ALLEGEDLY CAUSED DISCOMFORT. INSERTION WAS EITHER DIFFICULT OR IMPOSSIBLE.

  Patient problems: Discomfort

  MAUDE report 6717369 ↗
• MalfunctionJul 17, 2017Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY MAKING IT DIFFICULT TO INSERT. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6717213 ↗
• MalfunctionJul 17, 2017Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY MAKING IT DIFFICULT TO INSERT. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717140 ↗
• MalfunctionJun 19, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY. THE COMPLAINANT ALLEGED THAT HE WAS ABLE TO INSERT SOME OF THE CATHETERS. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6650081 ↗
• MalfunctionJun 19, 2017Difficult to Insert

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY. THE COMPLAINANT ALLEGED THAT HE WAS ABLE TO INSERT SOME OF THE CATHETERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6650015 ↗