Personal Catheter™ Intermittent Catheter 61612Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741069031), received between May 23, 2017 and Sep 15, 2017 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Product Quality Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2017Product Quality Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THERE WERE THREE ISSUES CONCERNING NUMEROUS CATHETERS THAT THE PATIENT RECEIVED. THERE WAS NO WATER SACHET, HOWEVER THE CATHETER WAS INCLUDED. THE SACHET WAS CUT AND THE CATHETER HAD A SHARP TIP, WHICH CAUSED BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6868318 ↗
• MalfunctionJul 5, 2017Material Deformation

  IT WAS REPORTED THAT AN INTERMITTENT SILICONE CATHETER WITH A CURVED END WAS RECEIVED AT BMD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6688698 ↗
• MalfunctionJun 9, 2017Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER WAS DRY. THE PATIENT ALLEGEDLY EXPERIENCED DISCOMFORT DURING INSERTION. ALSO, THE PATIENT WAS UNAWARE THAT THE CATHETER'S TIP APPEARED SHARP, AND HAD ABOUT 2 INCHES CUT OFF FROM THE BOTTOM. ALLEGEDLY, THIS CAUSED PAIN DURING INSERTION.

  Patient problems: Pain

  MAUDE report 6632604 ↗
• MalfunctionMay 23, 2017Packaging Problem

  IT WAS REPORTED THAT SOME OF THE PRODUCTS APPEARED TO BE PACKAGED THE WRONG WAY AROUND. THEREFORE, WHEN THEY WERE OPENED, THE USER HAD TO HOLD THE END THAT WAS TO BE INSERTED INSTEAD OF THE HANDLE END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6586238 ↗
• MalfunctionMay 23, 2017Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE CATHETER WAS PACKAGED UPSIDE DOWN. THE PATIENT WAS HAVING TO USE SCISSORS TO CUT THE OPPOSITE END AND GET THE CATHETER OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6585339 ↗