SpeediCath Standard 28492Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932020398), received between Apr 8, 2020 and Oct 15, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequate or Insufficient Training” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Inadequate or Insufficient Training; Inadequate or Insufficient Training

  THIS COMPLAINT CONCERNS A MALE END USER WHO HAS USED A SPEEDICATH STANDARD CH12 TIEMANN CATHETER. THE END USER HAD BEEN USING CH12 TIEMANN CATHETERS FOR A FEW WEEKS WITHOUT COMPLICATIONS, HOWEVER ONE DAY, DUE TO NOT BEING CLEAR ON WHICH DIRECTION TO INSERT THE CATHETER, HAD EXPERIENCED A LOT OF BLEEDING. THE END USER MENTIONS THAT IT TOOK APPROXIMATELY A DAY FOR THE BLEEDING TO STOP. THE END USER HAD UNDERGONE A CYSTOSCOPY TO INVESTIGATE IF ANY FURTHER UNDERLYING COMPLICATIONS MIGHT HAVE BEEN ASSOCIATED WITH THE ISSUE. WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Syncope/Fainting

  MAUDE report 23300015 ↗
• InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO AVAILABLE INFORMATION, THE COMPLAINT CONCERNS AN (B)(6) YEAR-OLD MALE END USER, WHO WAS A NEW USER TO CATHETERS (HAS USED CATHETERS 7 TIMES). ON (B)(6) 2021, HE EXPERIENCED BLOOD IN THE SC TIEMANN CATHETER (COUDÉ) BUT DID NOT FEEL ANY PAIN DURING CATHETERIZING. THE SAME NIGHT HE STARTED GETTING CHILLS AND CALLED HCP. THE HCP ADVISED END USER TO COME TO THE HOSPITAL. HE WAS HOSPITALIZED FOR TWO DAYS AND A FOLEY CATHETER WAS PLACED AT THE HOSPITAL. THE HCP DID NOT GIVE THE PATIENT A DEFINITE ANSWERED WHAT HAPPENED, BUT HE DID HAVE A STAFF INFECTION. THE END USER THINKS HE INSERTED THE CATHETER TOO FAR UP. AT FOLLOW-UP, IT IS STATED THAT THE END-USER CURRENTLY IS NOT USING CATHETERS AND NO FOLEY CATHETER WAS PLACED. IT IS NOT STATED IF THE PATIENT RECEIVED MEDICATION TO CLEAR THE INFECTION. NO OTHER INFORMATION WAS RECEIVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11851347 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A (B)(6) YEARS OLD MALE. HE IS A SEVERE DIABETIC AND HAS HAD A QUADRUPLE HEART BYPASS. IN EARLY (B)(6) 2020, HE CATHETERIZED 4 TIMES WITH A COLOPLAST SAMPLE BOX OF SC TIEMANN CH12 (ITEM 284920), AFTER WHICH HE EXPERIENCED A URINARY TRACT INFECTION (UTI) AND KIDNEY INFECTION (WHICH IS ALSO A UTI). HE WAS ADMITTED TO HOSPITAL AND WAS TREATED WITH ANTIBIOTICS (NO FURTHER INFORMATION AVAILABLE REGARDING THE TREATMENT). HE WAS DISCHARGED AFTER 5 DAYS AND IS NO LONGER CATHETERIZING. THE PATIENT HAS FULLY RECOVERED FROM THE UTI/KIDNEY INFECTION AND, ACCORDING TO THE INFORMATION OBTAINED, DID NOT SUFFER PERMANENT INJURIES.

  Patient problems: Urinary Tract Infection

  MAUDE report 9938110 ↗