SpeediCath Compact 28814Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05708932020633), received between Aug 4, 2016 and Aug 26, 2022 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2022Sharp Edges; Sharp Edges

  ACCORDING TO THE INFORMATION AVAILABLE, THIS COMPLAINT DESCRIBES A HARM TO A FEMALE END-USER WHO HAVE BEEN CATHETERIZING WITH SPEEDICATH COMPACT PLUS FOR MORE THAN 2 YEARS. THE END-USER STATED THAT SHE USED TWO CATHETERS WITH ROUGH EYELETS THAT SCRATCHED HER URETHRA UPON ENTERING AND WITHDRAWING THE CATHETER. THE END-USER STATED IT WAS PAINFUL TO USE THE CATHETERS BUT CONFIRMED THERE WAS NO BLEEDING. THE END-USER STATED THAT THREE DAYS AFTER USING THE ROUGH CATHETERS, SHE HAD TO GO TO THE EMERGENCY ROOM DUE TO A KIDNEY INFECTION. THE END-USER WAS HOSPITALIZED FOR FOUR DAYS. SHE WAS TREATED WITH AN 18-DAY ANTIBIOTIC INFUSION TREATMENT. THE END-USER HAS SINCE RECOVERED FOR THE KIDNEY INFECTION. IT IS UNCLEAR IF THE END-USER CONTINUES TO PERFORM INTERMITTENT SELF- CATHETERIZATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Kidney Infection; Pain

  MAUDE report 15299942 ↗
• InjuryMay 31, 2022Inadequate or Insufficient Training; Inadequate or Insufficient Training

  ACCORDING TO THE INFORMATION AVAILABLE, THIS COMPLAINT DESCRIBES AN INCIDENT WHERE A FEMALE END-USER WAS USING A SAMPLE OF SPEEDICATH COMPACT FEMALE PLUS. WHILE CATHETERIZING THE END-USER EXPERIENCED BLEEDING AND INFECTION AND ENDED UP IN HOSPITAL HAVING SURGERY DUE TO THE INFECTION. THE END-USER HAS FULLY RECOVERED AND IS NOW CATHETERIZING WITH ANOTHER COLOPLAST CATHETER. NOT MUCH INFORMATION IS AVAILABLE ABOUT THE INCIDENT, BUT IT SEEMS THAT THE END-USER FOLLOWED THE INSTRUCTION FROM A HEALTH CARE PROFESSIONAL ON HOW TO PERFORM CATHETERIZATION, AND THIS INFORMATION IS STATED BY THE END-USER TO BE ¿POOR¿. THERE IS NO INFORMATION ON THE DURATION OF HOSPITALIZATIONS OR THE TYPE OF SURGERY NOR ON THE AMOUNT OF BLEEDING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Kidney Infection; Localized Skin Lesion

  MAUDE report 14547552 ↗
• InjuryMay 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, A FEMALE END-USER INFORMS THAT DURING THE LAST YEAR SHE HAS HAD 10 URINARY TRACT INFECTIONS (UTIS) AND 19 HOSPITAL STAYS DUE TO CATHETERISING. DURING THE LAST 30 YEARS SHE HAS HAD RECURRENT UTIS AND HOSPITALIZATION. THE END-USES STATES THAT IT IS NOT A PROBLEM WITH THE CATHETERS, THEY ARE NOT DEFECTIVE. THE END-USER ALSO INFORMS THAT SHE HAS BEEN HOSPITALIZED OVERNIGHT MANY TIMES OVER THE YEARS OF CATHETERIZING AND SHE HAS SEEN MANY DOCTORS ABOUT HOW TO STOP THE UTI'S FROM HAPPENING, BUT NO SOLUTION HAS BEEN FOUND YET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Urinary Tract Infection

  MAUDE report 11802751 ↗
• InjuryJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS CASE INVOLVES A FEMALE END USER THAT HAD BEEN USING THE SPEEDICATH CATHETERS FOR ABOUT 5 DAYS WHEN SHE EXPERIENCED PAIN IN HER SIDE. SHE WENT TO HOSPITAL WHERE SHE WAS DIAGNOSED WITH COVID AND SEPSIS AND WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020. SHE WAS INFORMED BY THE PHYSICIAN IN THE COVID UNIT THAT THE SEPSIS WAS CAUSED BY CATHETERIZATION AND WAS TREATED WITH ANTIBIOTICS. THE END USER CLAIMS SHE HAD SOME CHALLENGES USING THE CATHETERS BUT DISPOSED OF THE CATHETERS CORRECTLY. THE END USER WAS MOVED TO THE REHAB WARD ON (B)(6) 2020. FOLLOWING HER DISCHARGE TESTS WERE PERFORMED AND SHE NOW BELIEVES THE SEPSIS IS HEALED. SHE WAS TOLD SHE MAY NEED TO TAKE ANTIBIOTICS FOR THE REST OF HER LIFE. THE END USER HAS FOLLOW-UP APPOINTMENTS WITH HER PRIMARY CARE PHYSICIAN AND UROLOGIST SCHEDULED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Sepsis

  MAUDE report 11232531 ↗
• InjuryAug 4, 2016Device Operates Differently Than Expected

  ACCORDING TO THE INFORMATION RECEIVED, PRODUCT NOT EXTENDING ALL THE WAY. END USER STATED THAT BECAUSE SHE DID NOT HAVE ANY MORE CATHETERS, SHE THEN TRIED TO PULL ONE OUT WITH HER TEETH AND SOMEHOW DAMAGED HER TEETH. SHE WAS NOT ABLE TO GET THE CATHETERS TO FULLY EXTEND. I DO NOT KNOW THE EXTENT OF THE DAMAGE TO HER TEETH.

  Patient problems: Tooth Fracture

  MAUDE report 5848356 ↗