Magic3 Go™ Intermittent Urinary Catheter 51808Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741097836), received between Dec 7, 2020 and Jun 9, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 20, 2023Class IIOpen, Classified

   Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.

   Z-1698-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED URINARY TRACT INFECTION FROM MAGIC 3 GO. INTERMITTENT SILICON CATHETER, WHICH CAUSED KLEBSIELLA AMMONIA. DISTRIBUTER HAVE GIVEN NEW SUPPLIES OF CATHETERS BUT CAUSED HOSPITAL STAY OF 6 DAYS AND NOW CUSTOMER WAS ON OXYGEN AND HEALTH HAS FAILED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Bacterial Infection; Urinary Tract Infection

  MAUDE report 17097768 ↗
• MalfunctionDec 31, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT THE ONE BOX OF 30 MAGIC3 GO INTERMITTENT CATHETER WHICH ALMOST AN ENTIRE CASE CAME WITH NO LIQUID IN THE BURST PACKET. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THIS PRODUCT MORE THAN 90 DAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13127108 ↗
• MalfunctionDec 7, 2020Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CATHETER WAS STIFF AND NOT LUBRICATED ENOUGH, WHICH CAUSED DISCOMFORT. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Discomfort

  MAUDE report 10962205 ↗