Magic3 Go Male Catheter with SureGrip 53820GRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741136993), received between Mar 25, 2019 and Aug 2, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 reports).

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-1699-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER WERE DRY, HERE AND THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258970 ↗
• MalfunctionJun 24, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT WOULD NOT VOID ANYTHING BUT DONT KNOW HOW FAR THE CATHETER SHOULD BE INSERTED. THE PATIENT GOT A PINCH SORT OF PAIN BUT HAD NO BLEEDING AND WANTED SMALLER SAMPLES.

  Patient problems: Pain

  MAUDE report 10192135 ↗
• MalfunctionOct 15, 2019Product Quality Problem; Defective Device; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS WERE NOT LUBRICATED ENOUGH, AND HE HAD TO ADD STERILE WATER TO THEM.

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

  MAUDE report 9192334 ↗
• MalfunctionMar 25, 2019Difficult to Insert; Product Quality Problem; Product Quality Problem

  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 8447480 ↗