Magic3 Touchless™ Hydrophilic Intermittent Catheter System 58814Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741104053), received between Jun 28, 2017 and Nov 20, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

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 18, 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.

• MalfunctionNov 20, 2018Product Quality Problem; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE HYDROGEL CATHETER FROM THE HYDROGEL CATHETER KIT HAD A LACK OF LUBRICITY.

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

  MAUDE report 8091562 ↗
• MalfunctionSep 13, 2018Short Fill

  IT WAS REPORTED THAT THE WATER SACHET IN THE CATHETER KIT WAS EMPTY.

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

  MAUDE report 7873640 ↗
• InjuryJul 16, 2018Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHILE USING THE TOUCHLESS MAGIC 3 CATHETER. IT WAS ALSO NOTED THAT THE PATIENT IS ON HIS THIRD ROUND OF ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 7691357 ↗
• MalfunctionOct 17, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETERS LACKED LUBRICITY. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT DUE TO THE CATHETERS BEING USED FOR A TRAINING DEMONSTRATION FOR HEALTH PROFESSIONALS.

  Patient problems: No Patient Involvement

  MAUDE report 6955850 ↗
• MalfunctionJul 19, 2017Failure To Adhere Or Bond

  IT WAS REPORTED THAT THE INDUCER TIP WAS NOT SEALED INSIDE OF THE BAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6727200 ↗
• MalfunctionJun 28, 2017Complete Blockage; Structural Problem

  IT WAS REPORTED THAT ONCE THE WATER SACHET WAS BURST IT MADE THE HYDROPHILIC COATING VERY THICK AND CAKE LIKE. THE CONSISTENCY OF THE COATING CLOGGED THE CATHETER.

  Patient problems: No Information

  MAUDE report 6675936 ↗