Magic3 Touchless™ Hydrophilic Intermittent Catheter System 58812Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741104046), received between Nov 14, 2018 and May 22, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION DURING USE OF THE MAGIC 3 CATHETER. THE URINARY TRACT INFECTION WAS REPORTEDLY TREATED WITH PRESCRIBED SULFAMETHOXAZOLE/TRIMETHOPRIM ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8633283 ↗
• MalfunctionNov 14, 2018Product Quality Problem; Product Quality Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE WATER PACKET CAUSED THE CATHETERS TO BECOME STICKY AND NOT LUBRICIOUS. THE PATIENT WAS ABLE TO USE THE CATHETERS; HOWEVER THEY WERE ALLEGEDLY UNCOMFORTABLE UPON INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; No Consequences Or Impact To Patient

  MAUDE report 8071956 ↗