Personal Catheter™ Intermittent Catheter 62608Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741069130), received between Aug 1, 2017 and May 12, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE DURING USE, FOLLOWED BY REVIEW OF A PATIENT THEY HAD REPORTED ISSUE WITH PASSING THEIR HYDROSIL SIZE 8 CATHETER CODE 62608P FOR THE LAST 3 WEEKS. THESE WERE DELIVERED BY SCRIPTEASY DELIVERY COMPANY. WHEN THE ISSUE OCCURRED, THEY FELT THERE WAS A SIZE DISCREPANCY. AT THE CLINIC, CUSTOMER BROUGHT INTERMITTENT CATHETERS THAT DID VISUALLY APPEAR TO BE SLIGHTLY DIFFERENT. THEY WOULD BE GRATEFUL IF THEY WERE ABLE TO LOOK INTO THIS ISSUE FOR THEM. THEY HAVE THE FOLEY CATHETERS IF THEY REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22002491 ↗
• MalfunctionMay 5, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE HYDROSIL CATHETER SIZE HAD DISCREPANCY. PER ADDITIONAL RECEIVED ON 23APR2025, PARENTS STRUGGLED TO PASS THE CATHETER ON SEVERAL OCCASIONS AND NOTED SIZE DISCREPANCIES WITH THE CATHETERS. REQUIRED MULTIPLE ATTEMPTS TO CATHETERISE CHILD DUE TO ISSUES WITH CATHETER, FELT THINNER CATHETER WAS DIFFICULT TO PASS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960341 ↗
• MalfunctionMay 4, 2021Improper Chemical Reaction; Improper Chemical Reaction

  IT WAS REPORTED THAT THE MAGIC 3 INTERMITTENT CATHETER HAD DIFFERENT LUBRICATION CONSISTENCY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773265 ↗
• MalfunctionApr 20, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE WATER PACKET FOR THE INTERMITTENT CATHETER WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11695503 ↗
• MalfunctionMar 19, 2020Fluid/Blood Leak; Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAKAGE WITH THE CATHETER. PER ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT VIA EMAIL ON 26FEB2020, FLUID LEAKED OUT WHEN THE PACKAGING WAS OPENED AND "NOT STAYING TOGETHER. PER ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER CONTACT VIA PHONE ON 26FEB2020, IT WAS NOTED THAT THERE WAS NO LEAKAGE WITH THE DEVICE, HOWEVER, THE CATHETER REPORTEDLY WOULD LOOSE LUBRICATION IN THE MIDDLE OF CATHING AND SOMETIMES IT WAS NOT LUBRICATED ENOUGH TO INSERT SO THE PATIENT EXPERIENCED PAIN WITH INSERTION. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 9853187 ↗
• MalfunctionApr 23, 2018Incorrect Measurement; Incorrect Measurement; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS THICKER THAN USUAL.

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

  MAUDE report 7452956 ↗
• MalfunctionApr 23, 2018Product Quality Problem; Product Quality Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE CATHETER WAS NOT AS SLIPPERY AS PREVIOUS ONES.

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

  MAUDE report 7452375 ↗
• MalfunctionSep 22, 2017Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE TWO SEALED, CONJOINED CATHETERS HAD A DIFFERENT THICKNESS DESPITE BEING 8CH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6888524 ↗
• MalfunctionAug 9, 2017Product Quality Problem; Defective Device

  IT WAS REPORTED THAT EXCESS SILICON REMAINED ON THE CATHETER FROM WHERE THE EYELET WAS PUNCTURED; THE EXTRA PIECE WAS ATTACHED TO THE OUTSIDE OF THE CATHETER. THE COMPLAINANT ALSO NOTED THAT THERE WAS A POSSIBILITY THAT THE PIECE COULD BREAK OFF INTO THE PATIENT DURING INSERTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6780051 ↗
• MalfunctionAug 1, 2017Manufacturing, Packaging or Shipping Problem; Packaging Problem

  IT WAS REPORTED THAT THE CATHETERS FROM THE SAME BOX, HAVE DIFFERENT DIAMETERS.

  Patient problems: No Information

  MAUDE report 6758807 ↗