HydroSil Go™ Intermittent Urinary Catheter 71814Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741098017), received between Feb 6, 2018 and May 23, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS CONFIRMED THAT DURING THE MONTH OF APRIL, THEY CONTRACTED A UTI. IT HAS BEEN CONFIRMED THAT THE PATIENT WAS USING THE CATHETER DURING THIS MONTH. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR THE INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 16986386 ↗
• MalfunctionMar 29, 2021Component Missing; Incomplete or Missing Packaging; Component Missing; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE PROBE WAS MISSING FROM THE BLISTER PACK DURING A DEMONSTRATION. THEY HAD ONLY THE CUP AND NOT YET ABLE TO CHECK OTHERS LIKE THAT IN THE BOX..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11584751 ↗
• MalfunctionMay 1, 2019Break

  IT WAS REPORTED THAT THE CATHETER WAS BROKEN.THIS OCCURRED PRIOR TO USE.

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

  MAUDE report 8570593 ↗
• MalfunctionJan 15, 2019Material Deformation; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS WAVY, THEREFORE NOT USABLE.

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

  MAUDE report 8249365 ↗
• MalfunctionJan 15, 2019Material Integrity Problem; Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE CATHETER WAS WAVY,THEREFORE NOT USABLE.

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

  MAUDE report 8249359 ↗
• MalfunctionFeb 28, 2018Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS WAVY AND UNUSABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7302765 ↗
• MalfunctionFeb 6, 2018Device Inoperable; Material Deformation

  IT WAS REPORTED THAT THE CATHETER WAS WAVY AND UNUSABLE.

  Patient problems: No Information

  MAUDE report 7244334 ↗