SpeediCath Standard 28496Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932020411), received between Dec 2, 2021 and Jul 16, 2025 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE END USER RECEIVED A COUPLE SAMPLES OF SPEEDICATH AND AFTER USING THEM, HE WAS BLEEDING AND HAD TO BE ADMITTED TO THE HOSPITAL. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22519522 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT IS FOR A (B)(6) MALE END-USER. THE END-USER IS NEW TO PERFORMING INTERMITTENT CATHETERIZATIONS. HE HAD USED THE CATHETERS FOR APPROXIMATELY 7 DAYS WITH MINOR BLEEDINGS TO BEGIN WITH, WHICH HE WAS INFORMED BY HIS UROLOGIST WAS NORMAL. ON THE (B)(6) HE EXPERIENCED MORE BLEEDING AFTER CATHETERIZING, WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL FOR 3 DAYS, DURING WHICH A FOLEY CATHETER WAS INSERTED, AND SEVERAL BLADDER WASHOUTS WAS PERFORMED. THE FOLEY CATHETER WAS REMOVED THE (B)(6), AND THE UROLOGIST HAS ENCOURAGED THE END-USER TO TRY AND VOID ON HIS OWN, BUT IF THIS IS UNSUCCESSFUL, HE SHOULD CONTINUE WITH THE CATHETERIZATIONS. FOR NOW, HE IS VOIDING ON HIS OWN AND HAVE A FOLLOW-UP WITH HIS UROLOGIST LATER. THE END-USER WAS ON BLOOD THINNER MEDICATION WHEN THE INCIDENT HAPPENED. THE END-USER HAD NOT NOTICED ANY DAMAGE TO THE CATHETER, OR PACKAGING. IT IS STATED THAT THE CATHETER WAS PROPERLY LUBRICATED AND NO SHARP EDGES. THE-USER CONFIRMS THAT HE WAS TRAINED IN USED THE CATHETERS CORRECTLY AND STATES HE USED THEM CORRECTLY.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12915761 ↗