SpeediCath Flex Coude Pro 20024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05708932125482), received between Nov 19, 2021 and Apr 6, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. 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.

• InjuryApr 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN 83-YEAR-OLD MALE END USER WHO SUFFERS FROM BPH. AFTER HAVING USED SC FLEX COUDÉ PRO ONLY ONCE ON (B)(6) 2023, HE FELT A BURNING SENSATION, WHICH KEPT HIM FROM CONTINUING TO USE CATHETERS. THE BURNING SENSATION LASTED FOR A COUPLE OF WEEKS, AFTER WHICH HE BEGAN TO URINATE BLOOD. THIS HAPPENED TWICE, AND HE WENT TO URGENT CARE AND WAS ADMITTED TO THE HOSPITAL, WHERE HE STAYED FOR 5 DAYS. HE HAD HIS BLADDER IRRIGATED AND A FOLEY CATHETER PUT IN, WHICH WAS REMOVED AFTER A WEEK. HE IS NOT CURRENTLY USING CATHETERS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 16689022 ↗
• InjuryNov 19, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT DESCRIBES AN EXPERIENCED (B)(6) YEAR OLD MALE END-USER, WHO AFTER CATHETERIZING WITH SPEEDICATH FLEX COUDÉ PRO EXPERIENCED BLEEDING AND AN URINARY TRACT INFECTION (UTI). THE END-USER WAS HOSPITALIZED FOR A COUPLE OF DAYS, WHERE A FOLEY CATHETER WAS PLACED FOR 4 DAYS. IN ADDITION, THE END-USER WAS GIVEN ANTIBIOTICS FOR 7 DAYS TO TREAT THE UTI. THE END-USER HAD USED SPEEDICATH FLEX COUDÉ PRO FOR A COUPLE OF YEARS. THE END-USER STATES THAT HE DID NOT NOTICE ANYTHING SHARP OR UNUSUAL WITH THE CATHETERS, BUT HE WAS MORE FORCEFUL THAN NORMAL. THE MEDICAL DOCTOR STATED THAT HE HAD CAUSED A SMALL CUT/WOUND ON HIS PROSTATE AND IRRITATED IT. THE CUT WAS ALSO STATED TO HAVE CONTRIBUTED TO THE UTI. THE END-USER HAD THE FOLEY CATHETER REMOVED AND IS INTERESTED IN CONTINUING TO CATHETERIZE WITH ANOTHER COLOPLAST CATHETER. THE UTI CLEARED UP AFTER THE ANTIBIOTIC TREATMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection

  MAUDE report 12842351 ↗