Magic3™ Intermittent Catheter 53516Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741068522), received between Apr 9, 2018 and Jun 10, 2019 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (4 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 16, 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.

• InjuryJun 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN URINARY TRACT INFECTION WHICH WAS TREATED WITH ANTIBIOTICS. THE PATIENT ADVISED VIA PHONE ON (B)(6) 2019 THAT HE HAD 3 UTI'S EACH WITHIN A WEEK OF RESUMING USE OF THE MAGIC 3 CATHETERS. THE PATIENT WAS NO LONGER USING THE CATHETERS AND WAS SCHEDULED FOR AN APPOINTMENT WITH HIS UROLOGIST TO DISCUSS HIS OPTIONS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8683095 ↗
• MalfunctionOct 17, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE LUBRICANT ON THE MAGIC 3 CATHETER FELT LIKE GLUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7975776 ↗
• MalfunctionOct 16, 2018Product Quality Problem; Difficult to Insert; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS NOT LUBRICATED MAKING THE CATHETER DIFFICULT TO INSERT.

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

  MAUDE report 7971485 ↗
• MalfunctionAug 5, 2018Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CATHETER FEELS THICKER THAN USUAL. NO MEDICAL INTERVENTION REPORTED. REASON FOR REPORT: INVESTIGATION RESULTS. REPORT ID NUMBER: (B)(6). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750734 ↗
• MalfunctionAug 5, 2018Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE PATIENT REPORTED THAT HE WAS UNABLE TO USE THE CATHETERS WITHOUT APPLYING ADDITIONAL LUBRICANT. REASON FOR REPORT: INVESTIGATION RESULTS. REPORT ID NUMBER: (B)(6). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750732 ↗
• MalfunctionApr 9, 2018Product Quality Problem; Product Quality Problem; Device Operates Differently Than Expected

  PER THE INVESTIGATION FOR ANOTHER FILE, IT WAS NOTED THAT 3 OF THE UNOPENED CATHETER SAMPLES FAILED THE LUBRICITY TEST.

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

  MAUDE report 7406708 ↗