SpeediCath Standard 28494Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05708932020404), received between Jan 11, 2018 and Apr 5, 2022 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO SUFFERS FROM CHRONIC URINARY RETENTION AND A SIGNIFICANTLY ENLARGED PROSTATE. HE HAS BEEN CATHETERISING FOR 6 YEARS WITH A STRAIGHT TIP CATHETER, BUT DUE TO HIS ENLARGED PROSTATE, HE STARTED USING SPEEDICATH COUDÉ CATHETERS IN (B)(6) 2021, AFTER BEING TRAINED. HE EXPERIENCED BLEEDING EVERY TIME AND WENT TO THE EMERGENCY ROOM TWO TIMES IN (B)(6) (THE FIRST ON (B)(6)2021). THERE WERE NO APPARENT DEFECTS WITH THE USED PRODUCT (E.G., NO SHARP OR ROUGH EDGES, ADEQUATE LUBRICATION), AND IT IS THUS UNLIKELY THAT THE BLEEDING IS RELATED TO A PRODUCT FAILURE. PRIOR TO THE FIRST VISIT, HE HAD LOST 2 PINTS OF BLOOD, WAS DIZZY, BUT DID NOT FAINT. HE RECEIVED A BLOOD TRANSFUSION AND STAYED IN THE HOSPITAL FOR 4 DAYS. HE RECEIVED MEDICATION IN HOPES OF REGAINING BLADDER FUNCTION, HAD A FOLEY CATHETER PLACED, WHICH WAS LATER REMOVED, AND WENT BACK TO INTERMITTENT CATHETERISATION. THE DATE AND LENGTH OF THE SECOND STAY IS NOT KNOWN. ON (B)(6)2022, HE WENT BACK TO USING SPEEDICATH STANDARD STRAIGHT TIP CATHETERS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14014344 ↗
• InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER WHO SUFFERS FROM CHRONIC URINARY RETENTION AND A SIGNIFICANTLY ENLARGED PROSTATE. HE HAS BEEN CATHETERISING FOR 6 YEARS WITH A STRAIGHT TIP CATHETER, BUT DUE TO HIS ENLARGED PROSTATE, HE STARTED USING SPEEDICATH COUDÉ CATHETERS IN (B)(6) 2021, AFTER BEING TRAINED. HE EXPERIENCED BLEEDING EVERY TIME AND WENT TO THE EMERGENCY ROOM TWO TIMES IN (B)(6) (THE FIRST ON (B)(6) 2021). THERE WERE NO APPARENT DEFECTS WITH THE USED PRODUCT (E.G., NO SHARP OR ROUGH EDGES, ADEQUATE LUBRICATION), AND IT IS THUS UNLIKELY THAT THE BLEEDING IS RELATED TO A PRODUCT FAILURE. PRIOR TO THE FIRST VISIT, HE HAD LOST 2 PINTS OF BLOOD, WAS DIZZY, BUT DID NOT FAINT. HE RECEIVED A BLOOD TRANSFUSION AND STAYED IN THE HOSPITAL FOR 4 DAYS. HE RECEIVED MEDICATION IN HOPES OF REGAINING BLADDER FUNCTION, HAD A FOLEY CATHETER PLACED, WHICH WAS LATER REMOVED, AND WENT BACK TO INTERMITTENT CATHETERISATION. THE DATE AND LENGTH OF THE SECOND STAY IS NOT KNOWN. ON (B)(6) 2022, HE WENT BACK TO USING SPEEDICATH STANDARD STRAIGHT TIP CATHETERS.

  Patient problems: Exsanguination

  MAUDE report 14014343 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THIS COMPLAINT CONCERNS A MALE END USER DIAGNOSED WITH BENIGN PROSTATE HYPERPLASIA (BPH) (ENLARGED PROSTATE), CAUSING RETENTION, FOR WHICH HE NEEDS TO USE CATHETERS. HE HAS BEEN USING SC STANDARD COUDÉ (TIEMANN). SOMETIMES, HE IS UNABLE TO GET THE CATHETER AROUND THE PROSTATE, AND SCRATCHES UP AGAINST THE PROSTATE, WHICH CAUSES BLEEDING. UPON REMOVAL, ABOUT 2-3 INCHES OF BLOOD IS SEEN ON THE CATHETER TIP, BUT HE DOES NOT EVER HAVE BLOOD IN HIS URINE, AND NO PROFUSE BLEEDING OCCURS IN BETWEEN CATHETERISATIONS. WHEN HE EXPERIENCES BLEEDING, THIS IS USUALLY ALSO ASSOCIATED WITH DEEP PAIN AND DISCOMFORT. THE PAIN FROM USING THESE CATHETERS LEAVES HIM FEELING TOO RAW AND UNCOMFORTABLE TO CONTINUE USING CATHETERS REGULARLY, AND HE USUALLY HAS TO WAIT A COUPLE OR FEW DAYS BEFORE USING HIS CATHETERS AGAIN. HE HAS A HISTORY OF DEVELOPING A UTI ABOUT EVERY 2 MONTHS OR SO. THE LAST TIME HE SCRATCHED HIS PROSTATE, HE ENDED UP IN THE HOSPITAL DUE TO HAVING A URINARY TRACT INFECTION (UTI) THAT BECAME SEPTIC. HE WAS ADMITTED TO THE HOSPITAL AROUND ON (B)(6)2021 AND WAS DISCHARGED ON (B)(6) 2022. HE HAD A FOLEY CATHETER PLACED AND GOT MEDICATION FOR THE INFE

  Patient problems: Hematuria; Sepsis

  MAUDE report 13652399 ↗
• InjuryDec 15, 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 HAD BEEN PERFORMING INTERMITTENT SELF-CATHETERIZATIONS FOR 10 YEARS AND HAD UNTIL RECENTLY USED SELF-CATH COUDÉ (TIEMANN). NOW HE WANTED PRE-LUBRICATED CATHETERS AND WAS SENT SAMPLES OF SPEEDICATH TIEMANN. THE FIRST SPEEDICATH CATHETER HE INSERTED WENT IN SMOOTHLY AND WITHOUT PROBLEMS, BUT THE SECOND WAS PAINFUL AND HE STARTED BLEEDING BEFORE HE ENTERED BLADDER. THE END-USER STATES THAT AFTER THIS HE COULD NOT INSERT ANY CATHETER, SELF-CATH NOR SPEEDICATH, AND HE HAD TO GO TO THE EMERGENCY ROOM. AT THE EMERGENCY ROOM THE STAFF WERE UNABLE TO CATHETERIZE HIM VIA THE URETHRA, AND A PASSAGE TO THE BLADDER VIA THE ABDOMEN WAS CREATED AND AN INDWELLING CATHETER WAS PLACED IN THAT PASSAGE. THE END-USER HAD AN APPOINTMENT WITH HIS UROLOGIST THE DAY AFTER, AND THE UROLOGIST WAS ABLE TO CATHARIZED VIA THE URETHRA. THE UROLOGIST PLACED AN INDWELLING CATHETER VIA THE URETHRA THAT STAYED FOR 14 DAYS. HEREAFTER THE END-USER WAS ABLE TO SELF-CATHETERIZE AGAIN WITH THE SELF-CATH CATHETERS, WHICH HE WILL CONTINUE WITH. THE END-USER STATES THAT HE WAS USING THE CATHETERS PER INSTRUCTION FOR USE (IFU)

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 13010652 ↗
• InjuryOct 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FOR AN (B)(6) YEAR-OLD MALE END-USER. THE END-USER IS NEW TO PERFORMING INTERMITTENT CATHETERIZATIONS (IC). HE HAD USED THE CATHETERS FOR SEVERAL DAYS WITHOUT PROBLEMS, BUT THEN EXPERIENCED SEVERE BLEEDING WHEN CATHETERIZING. THE BLEEDING CONTINUED, AND HE WAS ADMITTED TO THE HOSPITAL FEELING VERY WEAK. SINCE HIS HEMOGLOBIN LEVELS WERE ACCEPTABLE, IT WAS EVALUATED THAT A BLOOD TRANSFUSION WAS NOT NECESSARY. THE END-USER WAS TESTED FOR IN INFECTION, BUT NONE WAS FOUND. THE BLEEDING STOPPED AFTER 24 HOURS, AND THE END-USER WAS ADMITTED FOR ONE NIGHT. CURRENTLY THE END-USER HAS AN INDWELLING CATHETER UNTIL FOLLOW-UP WITH A UROLOGIST IN A COUPLE OF WEEKS, WHERE IT WILL BE EVALUATED IF THE END-USER CAN RETURN TO IC. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12639567 ↗
• InjuryMay 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE INVOLVES A (B)(6) YEAR OLD MALE END USER WHO WHILE USING THE SPEEDICATH CATHETER WAS DIAGNOSED WITH A BAD URINARY TRACT INFECTION WHICH DEVELOPED INTO SEPSIS REQUIRING HOSPITALIZATION. THE END USER IS AWAITING A POSSIBLE OPERATION FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis; Urinary Tract Infection

  MAUDE report 11870183 ↗
• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE CONCERNS A (B)(6)-YEAR-OLD MALE END USER, WHO HAS BEEN CATHETERIZING SINCE MID-(B)(6) 2020. ON (B)(6) 2020, HE EXPERIENCED A MAJOR BLEEDING EVENT UPON CATHETERIZATION WITH A SC TIEMANN CATHETER. HE HAD MADE SURE THAT THE TIEMANN TIP WAS POINTING UP DURING INSERTION, AND THAT THERE WERE NO SHARP EDGES. THERE WERE NO DIFFERENCES NOTICED DURING USE WHEN COMPARED TO THE OTHER SC TIEMANN CATHETERS HE HAD BEEN USING SUCCESSFULLY IN THE PREVIOUS WEEKS. HE WAS HOSPITALIZED THE NEXT DAY ((B)(6) 2020). FLUSHING WITH SALINE WAS PERFORMED TO THIN OUT THE BLOOD CLOTS HE WAS EXPERIENCING, FOLLOWED BY SURGERY TO CAUTERIZE A WOUND TO STOP THE BLEEDING, WHICH LASTED ABOUT 12 HOURS (FROM THE CATHETERIZATION UNTIL THE SURGERY). NO INFECTIONS WERE NOTED. IT WAS STATED THAT HE HAD EXPERIENCED A SIMILAR INJURY 2-3 WEEKS PRIOR USING A DIFFERENT MANUFACTURERS CATHETER. HE WAS DISCHARGED FROM HOSPITAL ON (B)(6) 2020 AND IS NO LONGER USING CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11051066 ↗
• InjurySep 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A (B)(6) MALE EXPERIENCING URINARY RETENTION DUE TO AN ENLARGED PROSTATE, STARTING AROUND (B)(6) 2019. HE HAD NO PREVIOUS HISTORY OF URINARY RETENTION OR URINARY TRACT INFECTIONS (UTIS). A FOLEY CATHETER WAS INSERTED ON (B)(6) AND REMOVED ON (B)(6). AS THE RETENTION REMAINED, HE WAS TRAINED TO USE INTERMITTENT CATHETERS AND WAS PRESCRIBED STRAIGHT CATHETERS. BY MISTAKE, HE RECEIVED ONE SAMPLE OF SPEEDICATH TIEMANN (COUDE) FROM THE DOCTOR'S OFFICE (NOT FROM COLOPLAST) THAT HE USED, DESPITE HIS LACK OF TRAINING IN THIS TYPE OF CATHETER. THIS RESULTED IN A SCRATCH AND SOME DISCOMFORT FOR A FEW HOURS, BUT HE DID NOT HAVE EXCESSIVE BLEEDING, AND THE PAIN SUBSIDED. A FEW HOURS LATER, HE WENT INTO THE EMERGENCY ROOM WITH FEVER-LIKE SYMPTOMS AND WAS HOSPITALIZED FROM (B)(6) TO (B)(6). THE PATIENT HAD BLOOD TESTS AND URINE SAMPLES TAKEN IN THE EMERGENCY ROOM ON (B)(6). HE WAS PLACED ON MEDICATION (NOT FURTHER SPECIFIED), WHICH HE TOOK FOR 5 DAYS. BY (B)(6), THE UTI HAD CLEARED, AND HE HAS NOT HAD ANY FURTHER ADVERSE EFFECTS. NO MORE FOLLOW-UP WITH THE DOCTOR'S OFFICE IS NEEDED ON THIS MATTER, AND HE IS NOW USING STRAIGHT CATHETERS WITH NO COMPLAINTS.

  Patient problems: Urinary Tract Infection

  MAUDE report 9071418 ↗
• InjuryJan 11, 2018Partial Blockage; Device Operates Differently Than Expected

  ACCORDING TO THE AVAILABLE INFORMATION, END USER EXPERIENCED A LARGE AMOUNT OF BLEEDING THAT HE ATTRIBUTES TO THE SPEEDICATH COUDE. HE WAS PRESCRIBED A STRAIGHT TIP BUT PROVIDED COUDE FROM THE DR OFFICE. HE ENDED UP NOT BEING ABLE TO KEEP THE SPEEDICATH COUDE POINTED UP AND CAUSED A LARGE AMOUNT OF BLEEDING. UROLOGIST PUT HIM BACK ON A FOLEY. DAYS LATER, HE ENDED UP GOING TO THE E.R. BECAUSE THE FOLEY AND BAG GOT PLUGGED UP BY THE BLOOD. EU IS BACK ON STRAIGHT SPEEDICATH AFTER BLEEDING HAD STOPPED. OUTCOME: END USER O LONGER EXPERIENCING BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7182172 ↗