Magic3™ Intermittent Catheter 53316Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741068430), received between Aug 18, 2017 and Apr 8, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2020Difficult to Insert; Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE PATIENT INSERTED THE CATHETER WITHOUT LUBRICANT. IT WAS DIFFICULT TO DIFFICULT TO INSERT AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Blood Loss; Patient Problem/Medical Problem

  MAUDE report 9934130 ↗
• MalfunctionMar 18, 2020Sharp Edges

  IT WAS REPORTED THAT THE PATIENT SAID THE CATHETER WAS SHARP AND CAUSED BLEEDING. NO MEDICAL INTERVENTION REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem

  MAUDE report 9848488 ↗
• MalfunctionOct 17, 2017Scratched Material

  IT WAS REPORTED THAT THE DRAINAGE EYES ON THE CATHETER HAD SHARP EDGES. ALLEGEDLY, THE PATIENT EXPERIENCED SCRAPING ON THE URETHRA; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Laceration(s)

  MAUDE report 6954293 ↗
• MalfunctionOct 17, 2017Defective Component

  IT WAS REPORTED THAT THE DRAINAGE EYES ON THE CATHETER HAD SHARP EDGES. ALLEGEDLY, THE PATIENT EXPERIENCED SCRAPING ON THE URETHRA; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion

  MAUDE report 6954222 ↗
• MalfunctionOct 17, 2017Material Deformation

  IT WAS REPORTED THAT THE DRAINAGE EYES ON THE CATHETER HAD SHARP EDGES. ALLEGEDLY, THE PATIENT EXPERIENCED SCRAPING ON THE URETHRA; HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Abrasion

  MAUDE report 6954220 ↗
• MalfunctionAug 25, 2017Material Integrity Problem

  IT WAS REPORTED THAT THERE WERE SHARP EDGES ON THE DISTAL END OF THE EYELETS OF THE CATHETER THAT SCRATCHED THE PATIENT AND CAUSED PAIN UPON REMOVAL OF THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Pain

  MAUDE report 6822358 ↗
• MalfunctionAug 18, 2017Scratched Material

  IT WAS REPORTED THAT THERE WERE SHARP EDGES ON THE DISTAL END OF THE EYELETS THAT CAUSED PAIN UPON INSERTION AND WORSE PAIN UPON REMOVAL. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Pain

  MAUDE report 6803378 ↗