Personal Catheter™ Intermittent Catheter 63616Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741069307), received between Jun 6, 2017 and Oct 6, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 6, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT MENTIONED THAT SOME OF THE FOLEY CATHETERS IN THE PACKAGE WERE NOT LUBRICATED SO COULD NOT BE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23222985 ↗
• MalfunctionJun 14, 2022Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE PATIENT WANTED TO GO BACK ONTO HYDROSIL GO AS FINDING THAT THE HYDROSIL GRIPPERS WERE NOT VERY GOOD QUALITY RECENTLY. ALSO STATED THAT EVEN WITH BURSTING THE WATER SACHET, THE INTERMITTENT CATHETERS JUST SEEM TO NOT AS LUBRICATED AS THEY USED TO BE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684429 ↗
• MalfunctionFeb 9, 2021Short Fill; Short Fill

  IT WAS REPORTED THAT ONE OF THE HYDROPHILIC CATHETERS HAD A BURST PACK THAT WAS EMPTY. PATIENT DID NOT USE THE CATHETER. WHILE THIS CATHETER WAS NOT SPECIFICALLY IDENTIFIED, IT WAS THE ONLY CATHETER, LIBERATOR MEDICAL SERVICE HAD PROVIDED TO THIS PATIENT FOR NUMEROUS YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11305388 ↗
• MalfunctionDec 6, 2019Product Quality Problem; Product Quality Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT STATED THE WATER PACK WAS SOMETIMES AT THE BOTTOM, AND SOMETIMES IN THE MIDDLE. WHEN IT WAS AT THE BOTTOM, IT DID NOT COAT THE CATHETER CORRECTLY.

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

  MAUDE report 9433896 ↗
• MalfunctionJan 4, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE EYELETS ON THE INTERMITTENT HYDRO MALE CATHETER WERE NOT SMOOTH AND HAD RIDGES AROUND THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8217900 ↗
• MalfunctionSep 27, 2017Component Missing

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY AND THE PATIENT FELT DISCOMFORT. THERE WAS NO MEDICAL INTERVENTION FOR THE DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 6896806 ↗
• MalfunctionAug 8, 2017Product Quality Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS NOT LUBRICATING.

  Patient problems: No Information

  MAUDE report 6775684 ↗
• MalfunctionJun 6, 2017Product Quality Problem

  IT WAS REPORTED THAT THE CATHETER DID NOT HAVE ENOUGH LUBRICANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614668 ↗