Personal Catheter™ Intermittent Catheter 63314Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741069178), received between Jul 29, 2021 and Jul 29, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD A BEND AT THE TIP AND IT MADE THE PATIENT BLEED. NO MEDICAL INTERVENTION REPORTED. THE REPRESENTATIVE ADVISED THE PATIENT THAT THESE SUPPLIES HAS BEEN DISCONTINUED AND THE PATIENT WILL RECEIVE DIFFERENT SUPPLIES GOING FORWARD.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12245322 ↗