SpeediCath Standard 28416Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708932020299), received between Apr 9, 2021 and Jan 3, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 16, 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.

• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS AN END USER (EU) WHO HAS BEEN USING SC STANDARD MALE CATHETER FOR A FEW MONTHS. THE EU HAS RECEIVED TRAINING IN SELF-CATHETERISATION BY THE DOCTOR AND CATHETERISES ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE EU HAS EXPERIENCED SOME TROUBLE PASSING THE CATHETER AROUND THE PROSTATE AS WELL AS PAIN/DISCOMFORT WHEN INSERTING. A FEW WEEKS AGO, THE EU EXPERIENCED BLEEDING AND REACHED OUT TO THE UROLOGIST. MORE RECENTLY (DATES NOT SPECIFIED), THE EU GOT A BLOOD INFECTION AND WAS ADMITTED TO THE HOSPITAL FOR AROUND A WEEK, WHERE THE EU WAS TREATED WITH IV ANTIBIOTICS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Sepsis

  MAUDE report 21065069 ↗
• InjuryApr 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A MALE PATIENT WHO EXPRESSED THAT HE HAD BEEN EXPERIENCING PAIN BOTH BEFORE AND AFTER RECEIVING COLOPLAST CATHETER SAMPLES. THE PAIN CONTINUED AS HE CATHETERIZED. HIS URINE WAS ALSO GOING AROUND THE CATHETER REGARDLESS OF WHICH SIZE HE USED. THE END USER WAS RUSHED TO THE HOSPITAL DUE TO EXCESSIVE PAIN AND AN INFECTION WAS FOUND. THE DR. IS TRYING TO FIGURE OUT HOW THE INFECTION HAPPENED AND IF IT WAS DUE TO THESE SUPPLIES OR SOMETHING UNDERLYING. THE LENGTH OF HOSPITAL STAY AND AFFECTED QUANTITY WERE NOT REPORTED. IT WAS ESTABLISHED THAT THE PATIENT HAS NOT USED THIS PRODUCT BEFORE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Pain; Urinary Tract Infection

  MAUDE report 16762186 ↗
• InjuryJun 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE CONCERNS A MALE END USER WHO WAS HOSPITALIZED DUE TO URINARY TRACT INFECTIONS THAT WERE THOUGHT TO HAVE BEEN CAUSED BY COLOPLAST SPEEDICATH STANDARD (MALE) CATHETERS. THE END USER IS NOT NEW TO USING THESE CATHETERS, BUT IT APPEARS THAT HE HAS TOUCHED THEM UPON INSERTION AND HAS REQUESTED FOR A DIFFERENT TYPE IN WHICH HE DOESN'T NEED TO DO THIS. ATTEMPTS WERE MADE TO THE END USER ON DURATION OF THE HOSPITAL STAY AND THE OUTCOME OF ANY TREATMENT. THESE ATTEMPTS WERE NOT ANSWERED AND NO FURTHER INFORMATION HAS BEEN PROVIDED IN REGARDS TO THIS CASE. END USER WILL BE SENT NEW CATHETERS TO TRY.

  Patient problems: Urinary Tract Infection

  MAUDE report 14630483 ↗
• InjuryAug 24, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE REPORT CONCERNS A (B)(6) YEAR-OLD MALE. HE HAD BEEN USING INTERMITTENT CATHETERS FROM (B)(6) 2021 BECAUSE OF URINARY RETENTION. ON THE (B)(6) 2021, HE WAS ADMITTED TO HOSPITAL WITH BLEEDING AND A URINARY TRACT INFECTION (STAPH INFECTION) AND WAS TREATED WITH ANTIBIOTICS. HE WAS DISCHARGED AFTER 5 DAYS HAVING RECOVERED FROM THE INFECTION AND IS CURRENTLY STILL CATHETERIZING FOUR TIMES A DAY WITH A DIFFERENT BRAND OF CATHETER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Abdominal Pain; Hematuria; Urinary Tract Infection

  MAUDE report 12362411 ↗
• InjuryApr 9, 2021Sharp Edges; Sharp Edges

  THE REPORT CONCERNS A (B)(6) YEARS-OLD MAN. HE EXPERIENCED BLEEDING AND PAIN ONE DAY AFTER STARTING TO USE SAMPLES OF SPEEDICATH STANDARD MALE URINARY INTERMITTENT CATHETERS THAT HE RECEIVED FROM HIS MEDICAL DOCTOR. AFTER A VISIT TO HIS UROLOGIST, HE WAS DIAGNOSED WITH BLADDER AND KIDNEY INFECTION AND RECEIVED ANTIBIOTICS TREATMENT FOR THE INFECTION. HE CONTINUED TO USE THE SPEEDICATH STANDARD CATHETERS, AS HE HAD NO OTHERS, AND HIS URINE WAS GETTING DARKER AND DARKER. HE IS AN EXPERIENCED USER AND HAVE PERFORMED INTERMITTENT CATHETERIZATION SINCE AROUND YEAR 2000. THE END-USERS STATED THAT THE CATHETERS FELT LIKE SAND-PAPER UPON INSERTION, THE SURFACE FELT ROUGH WHEN HE TOUCHED IT WITH HIS FINGERS, BUT THE CATHETERS WERE WET AND THERE WAS LIQUID INSIDE. AT FOLLOW-UP IT IS STATED THAT THE END-USER IS NOW RECOVERING, AND HE CONTINUES TO SELF-CATHETERIZE WITH INTERMITTENT CATHETERS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Urinary Tract Infection

  MAUDE report 11642461 ↗