Magic3™ Hydrophilic Intermittent Catheter, Male 53616GSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741072666), received between Feb 4, 2021 and Feb 5, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Expiration Date Error” (2 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 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.

• MalfunctionFeb 5, 2021Device Damaged Prior to Receipt by User; Expiration Date Error; Device Damaged Prior to Receipt by User; Expiration Date Error

  IT WAS REPORTED THAT THE CATHETER PACKAGING LABEL HAD THE INCORRECT EXPIRATION DATE AS 05/05/19, AND THE ACTUAL EXPIRATION DATE AS PER THE SYSTEM WAS 11/27/22 AND HAD SHORT COUNT SHIPMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11285152 ↗
• MalfunctionFeb 4, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT THE CATHETER PACKAGING LABEL HAD THE INCORRECT EXPIRATION DATE AS (B)(6) 2019, AND THE ACTUAL EXPIRATION DATE INDICATED IN THE SYSTEM WAS (B)(6) 2022. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2021, THE CORRECT EXPIRATION DATE WAS PLACED ON THE CATHETER PACKAGING LABEL. IT WAS JUST SHIPPED TO THE CUSTOMER EXPIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11279648 ↗