Personal Catheter™ Intermittent Catheter 63618Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741069314), received between Oct 17, 2017 and May 8, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (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.

• MalfunctionMay 8, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CUSTOMER STATED A PATIENT WAS UNABLE TO USE THE INTERMITTENT CATHETER AS THERE WAS NO ENOUGH LUBRICANT. I CONFIRM THAT ALL FOUR CATHETERS DID NOT HAVE ENOUGH LUBRICANT SO, COULD NOT BE USED. THE PATIENT HAS USED THIS PRODUCT FOR A LONG TIME SO, IS VERY FAMILIAR WITH IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16887478 ↗
• MalfunctionApr 27, 2023Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE CUSTOMER STATED A PATIENT WAS UNABLE TO USE THE INTERMITTENT CATHETER AS THERE WAS NO ENOUGH LUBRICANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823192 ↗
• MalfunctionDec 21, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE LUBRICANT OF INTERMITTENT CATHETERS WAS NOT SMOOTH WHEN INSERTING WITH RECENT ORDER BATCH#JUFN2580. AS PER SAMPLE EVALUATION RESULT RECEIVED ON 08DEC2021, IT WAS STATED THAT ADDITIONAL SAMPLE OF INTERMITTENT CATHETERS BELONGING TO DIFFERENT LOT NUMBER WAS RECEIVED BATCH#JUDU0191.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13057465 ↗
• MalfunctionNov 13, 2019Product Quality Problem; Product Quality Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CATHETERS POSSIBLY LACKED LUBRICATION. THE PATIENT ALLEGEDLY NOTICED BLEEDING DURING USE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Consequences Or Impact To Patient

  MAUDE report 9315355 ↗
• MalfunctionAug 5, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THERE IS NOT ENOUGH LUBRICANT IN THE WATER PACKETS AND THE CATHETERS FELT DRY. THEREFORE, THE PATIENT STATED THAT HE WAS UNABLE TO FULLY INSERT THE CATHETERS. REASON FOR REPORT: INVESTIGATION RESULTS. REPORT ID NUMBER: (B)(6). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750524 ↗
• MalfunctionAug 5, 2018Short Fill; Short Fill

  IT WAS REPORTED THAT THERE IS NOT ENOUGH LUBRICANT IN THE WATER PACKETS AND THE CATHETERS FELT DRY. THE PATIENT REPORTED THAT HE WAS THEREFORE UNABLE TO FULLY INSERT THE CATHETERS. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7750505 ↗
• MalfunctionOct 17, 2017Product Quality Problem

  IT WAS REPORTED THAT THE WATER PACKET WITH THE MAGIC 3 CATHETER DID NOT CONTAIN ENOUGH WATER TO LUBRICATE THE CATHETER. ALLEGEDLY THE CATHETER TORE THE PATIENT'S URETHRA AND IRRITATED THE TIP OF THE PATIENT'S PENIS. THERE WAS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Irritation; Laceration(s)

  MAUDE report 6954346 ↗
• MalfunctionOct 17, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER THE WATER PACKET WAS POPPED THE WATER DID NOT ADHERE TO THE CATHETER TO LUBRICATE THE CATHETER. NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954045 ↗