Magic3™ Intermittent Catheter 53514Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741068515), received between May 1, 2017 and Mar 10, 2020 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT WAS ALLEGEDLY GETTING URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9813700 ↗
• InjuryMar 10, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT ALLEGEDLY GOT URINARY TRACT INFECTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9813698 ↗
• MalfunctionJul 22, 2019Difficult to Insert

  IT WAS REPORTED THAT THE CATHETER WAS TOO LARGE AND DIFFICULT TO INSERT AND CAUSED THE PATIENT SOME PAIN. THE PATIENT WAS NOT ABLE TO FULLY INSERT THAT CATHETER FOR USE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8813097 ↗
• MalfunctionMay 23, 2019Product Quality Problem; Product Quality Problem; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY.

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

  MAUDE report 8635584 ↗
• MalfunctionMay 9, 2019Product Quality Problem; Therapeutic or Diagnostic Output Failure; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS DRY EVEN AFTER LUBRICANT WAS APPLIED.

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

  MAUDE report 8596892 ↗
• MalfunctionMar 29, 2019Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER LOOKED LARGER IN DIAMETER THAN USUAL. THERE WAS NO REPORTED IMPACT TO THE PATIENT BEING ABLE TO VOID.

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

  MAUDE report 8467227 ↗
• MalfunctionMar 29, 2019Filling Problem; Short Fill; Short Fill

  IT WAS REPORTED THAT THE WATER SACHET OF THE MAGIC 3 CATHETER WAS NOT FULLY FILLED.

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

  MAUDE report 8467224 ↗
• MalfunctionMar 29, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER HAD A LACK OF LUBRICITY MAKING IT DIFFICULT TO INSERT.

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

  MAUDE report 8467203 ↗
• MalfunctionDec 26, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE TIP OF THE MAGIC 3 CATHETER APPEARED LARGER THAN USUAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8197366 ↗
• InjurySep 5, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BLOOD CLOT DURING USE OF THE CATHETER AND REQUIRED HOSPITALIZATION.

  Patient problems: Patient Problem/Medical Problem; Thrombus

  MAUDE report 7846780 ↗
• MalfunctionAug 8, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETERS LACK LUBRICITY, THEREFORE MAKING THEM STICKY AND DIFFICULT TO REMOVE. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7764590 ↗
• MalfunctionAug 5, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETERS LACK LUBRICITY, MAKING THEM DIFFICULT TO INSERT. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750495 ↗
• InjuryAug 3, 2018Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION FOLLOWING USE OF THE MAGIC 3 CATHETER. THE UTI WAS REPORTEDLY TREATED WITH PRESCRIBED ANTIBIOTICS

  Patient problems: Urinary Tract Infection

  MAUDE report 7746903 ↗
• MalfunctionJun 22, 2018Short Fill

  IT WAS REPORTED THAT THE CATHETER WATER SACHET DID NOT HAVE ENOUGH WATER INSIDE OF IT.

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

  MAUDE report 7630360 ↗
• MalfunctionApr 17, 2018Product Quality Problem; Product Quality Problem; Component Missing; Difficult to Advance

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER LACKED LUBRICITY, AND DIFFICULT TO INSERT. IT WAS REPORTED THAT THE COMPLAINANT COATS THE MAGIC 3 CATHETERS WITH AN OVER THE COUNTER "SURGILUBE LUBRICANT" AND WAS STILL ABLE TO USE THE MAGIC 3 CATHETERS.

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

  MAUDE report 7437837 ↗
• MalfunctionJul 5, 2017Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER WAS DRY, THEREFORE THE PATIENT WAS UNABLE TO INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6688667 ↗
• MalfunctionMay 21, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE DEVICE LACKED LUBRICITY. THE COMPLAINANT STATED THAT THE WATER PACKET APPEARED TO HAVE THE CORRECT AMOUNT OF FLUID.

  Patient problems: No Information

  MAUDE report 6580827 ↗
• MalfunctionMay 9, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE WATER PACKET DID NOT CONTAIN ENOUGH LUBRICANT, AND THEREFORE IT WAS DIFFICULT TO INSERT THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6555490 ↗
• MalfunctionMay 8, 2017Defective Component; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS NOT SLIPPERY ENOUGH.

  Patient problems: No Information

  MAUDE report 6552209 ↗
• MalfunctionMay 1, 2017Component Missing

  IT WAS REPORTED THAT THE DEVICE LACKED LUBRICITY. THE WATER PACKET APPEARED TO HAVE ENOUGH LIQUID.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6534104 ↗