Personal Catheter™ Intermittent Catheter 63612Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741069284), received between Apr 10, 2017 and Dec 15, 2025 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Improper Chemical Reaction” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2025Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE ONE INTERMITTENT CATHETER IN THE BOX WAS BLOCKED ALL THE WAY DOWN THE INTO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23810477 ↗
• MalfunctionOct 22, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT DURING USE THE INTERMITTENT CATHETER WAS NOT WORKING WELL WERE OF BLUE COLOUR BUT THE ONES USED TO GET BEFORE OF GREEN COLOUR THAT WAS WORKING WELL. THE FLUID FOR LUBRICATION OF THE BLUE COLOURED CATHETER WAS NOT AS SMOOTH AS THE GREEN COLOURED OLD ONES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23357061 ↗
• MalfunctionSep 26, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT, WHEN HANDLING THE INTERMITTENT CATHETERS, IT WAS FOUND MOST OFTEN THAT A SLIGHT SLIT IN THE SKIN TO THE FINGERS. ON CLOSER EXAMINATION IT WAS FOUND THE EDGES OF THE SLEEVES HAD TINY SERRATIONS, SIMILAR TO A FILE OR EXTREMELY FINE CRAFT SAW, KNIFE BLADE. IT WAS RAZOR SHARP AND NOT EASY TO AVOID TOUCHING WHEN OPENING TO USE, OR TO PACK THE CATHETERS AWAY FOR DISPOSAL. USER FOUND THE USAGE VERY SPITEFUL AND UNCOMFORTABLE TO THE HANDS. CO-INCIDENTALLY, THIS HAD ONLY OCCURRED SINCE THE CHANGE FROM GREEN TO BLUE BOXES CONTAINING 30 CATHETERS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Discomfort; Skin Tears

  MAUDE report 23156186 ↗
• MalfunctionSep 22, 2025Wrong Label; Wrong Label

  IT WAS REPORTED THAT THEY HAD AN INCIDENT WHERE A CUSTOMER HAD RECEIVED A 63612 INSIDE A BOX LABELED 73612, THEIR CUSTOMER SERVICE TEAM HAD SAID THE PRODUCT THEY USED TO GET WAS IN A BLUE BOX. THIS WAS IN A GREEN BOX, AND IT SAYS 73612 ON THE BOX AND THE INTERMITTENT CATHETERS BUT THE PACKETS CONTAIN SOMETHING VERY DIFFERENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23108962 ↗
• InjurySep 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT STATED THAT THE LAST INTERMITTENT CATHETERS THAT WAS SENT OUT, WAS A DIFFERENT SIZE AND THEY HAD TO GET USED TO THAT AND THEN GAVE THEMSELVES A URINARY TRACT INFECTION. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 23083330 ↗
• MalfunctionSep 16, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT ADVISED THAT THEY NOTICED THE PACKAGING CHANGED ON THE LAST ORDER AND THE PATIENT SAID THEY CHECKED THE CODES AND THE SAME, SO THEY USED THEM BUT FOUND SOME DIFFERENCES. THE PATIENT SAID THE INDIVIDUAL SLEEVES WERE CRAMMED TOGETHER AND HARD TO SEPARATE. PATIENT ALSO SAID THE EDGES OF THE SLEEVES WERE VERY SHARP AND THEY GOT A FEW CUTS FROM THEM.

  Patient problems: Abrasion

  MAUDE report 23065418 ↗
• MalfunctionSep 8, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT, A DOZEN OF INTERMITTENT CATHETERS FROM ONE PACK DID NOT HAD SUFFICIENT LUBRICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999308 ↗
• MalfunctionJul 3, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT, ON THE LAST ORDER CUSTOMER RECEIVED, MOST OF THE INTERMITTENT CATHETERS TO BE DISPOSED OF AS CATHETER WERE NOT LUBRICATED ENOUGH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22395566 ↗
• MalfunctionJul 1, 2025Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT PATIENT ADVISED THAT THE WHOLE BOX DID NOT HAD ENOUGH LUBRICANT IN IT TO BE ABLE TO USE THE INTERMITTENT CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22373252 ↗
• MalfunctionJun 25, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT TWO INTERMITTENT CATHETERS FROM PREVIOUSLY DELIVERED WAS FULLY SOLID INSIDE CATHETER WITH NO DRAINAGE CHANNEL BORED THROUGH PRODUCT. NO DRAINAGE UPON INSERTION. ONLY 2 WERE AFFECTED, TOTAL 4 BOXES WERE SENT, REMAINING QUANTITY SUITABLE FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22328947 ↗
• MalfunctionMay 4, 2018Product Quality Problem; Product Quality Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY. THE PATIENT STATED THAT THE CATHETER MAY HAVE NOT BEEN WELL COATED DUE TO THE CATHETER BEING COATED FOR LESS THAN 25-30 SECONDS.

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

  MAUDE report 7487621 ↗
• MalfunctionNov 20, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE TUBING WAS TOO THICK AND THE CATHETER HAD BEEN CUT INCORRECTLY. IT WAS STATED THAT THE CHEMIST WAS CONCERNED BECAUSE THE CUSTOMER HAD ATTEMPTED TO USE THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7046280 ↗
• MalfunctionAug 24, 2017Material Protrusion/Extrusion

  IT WAS REPORTED BY THE PATIENT THAT THE CATHETERS HAD SHARP EDGES AND THE SALINE POUCHES HAD HOLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6818636 ↗
• MalfunctionMay 4, 2017Hole In Material; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE QUALITY OF THE PRODUCT WAS NOT LIKE IT USED TO BE. THE CATHETERS HAD SHARP EDGES AND THE SALINE POUCHES HAD HOLES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6545399 ↗
• MalfunctionApr 13, 2017Bent; Difficult to Advance

  IT WAS REPORTED THAT THE BATCH RECEIVED WAS "DISTORTED", AND THE ENDS/TIPS OF THE CATHETERS WERE BENT. THE PATIENT WAS NOT ABLE TO USE THE BENT CATHETERS, AS THEY MADE FOR A DIFFICULT INSERTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6489845 ↗
• MalfunctionApr 10, 2017Defective Component

  IT WAS REPORTED THAT THERE WAS WATER IN THE WATER SACHETS WAS INSUFFICIENT, AND THE USER WAS UNABLE TO ACTIVATE THE LUBRICATION ON THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6475708 ↗