Personal Catheter™ Intermittent Catheter 63512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741069239), received between Dec 28, 2018 and Apr 11, 2019 — classified as 1 injury, 2 malfunctions.

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

• InjuryApr 11, 2019Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility

  IT WAS REPORTED BY THE PATIENTS WIFE THAT THE USER IS PRONE TO GETTING INFECTIONS WITH THE INTERMITTENT ANTIBACTERIAL HYDROMALE EXTERNAL CATHETERS. THE PATIENT'S WIFE ADVISED THAT HE WOULD LIKE TO USE A CATHETER WITH A SLEEVE. THE URINARY TRACT INFECTION WAS TREATED WITH ANTIBIOTICS. THE PATIENT'S WIFE CONFIRMED VIA PHONE ON THE (B)(6) 2019, THAT LIBERATOR EXCHANGED THE MAGIC 3 CATHETERS FOR ONE WITH A SLEEVE AND NOTED THAT THERE WERE NO ISSUES TO DATE.

  Patient problems: Urinary Tract Infection

  MAUDE report 8504028 ↗
• MalfunctionJan 21, 2019Difficult to Insert

  IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO COMPLETELY INSERT THAT CATHETER AND VOID. THE PATIENT ALSO EXPERIENCED PAIN DURING INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 8265047 ↗
• MalfunctionDec 28, 2018Incorrect Measurement; Incorrect Measurement; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE DIAMETER OF THE CATHETER WAS TOO LARGE, ALLEGEDLY CAUSING THE PATIENT PAIN WITH INSERTION OF THE CATHETER. THE PATIENT WAS STILL ABLE TO USE THE CATHETER TO VOID.

  Patient problems: Pain

  MAUDE report 8204634 ↗