SpeediCath Compact Male 28702Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05708932653046), received between Jun 30, 2017 and Jun 25, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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.

• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE UDER INSERTED THE CATHETER AND EXPERIENCED PAIN. BLOOD WAS NOTED IMMEDIATELY AFTER. THE USER TOOK A SHOWER AND LAID DOWN BUT BEGAN TO EXPERIENCE CHILLS. THE USER THEN PROCEEDED TO THE HOSPITAL AND WAS TREATED FOR SEPTIC SHOCK. THE PATIENT WAS HOSPITALIZED FOR 6 DAYS.

  Patient problems: Chills; Pain; Septic Shock

  MAUDE report 7634811 ↗
• InjuryDec 7, 2017Material Too Rigid or Stiff

  ACCORDING TO THE AVAILABLE INFORMATION, USER EXPERIENCED HEAVY BLEEDING AFTER USING THE SPEEDICATH MALE COMPACT, TO THE EXTENT THAT HE WENT TO THE EMERGENCY ROOM AND SPENT 3 DAYS IN THE HOSPITAL. HE INITIALLY EXPERIENCED BLEEDING ON (B)(6) AT APPROXIMATELY 9PM. HE WOKE UP AT 11PM AND FELT THE URGE TO URINATE, WHICH WAS UNUSUAL FOR HIM. HE THEN NOTICE A LARGE AMOUNT OF BLOOD IN THE URINE AND WENT TO THE EMERGENCY ROOM. HE SPENT THE NEXT 3 DAYS IN THE HOSPITAL, HAVING LOST A SIGNIFICANT AMOUNT OF BLOOD. HE IS CURRENTLY ON BLOOD THINNERS. HE NOW HAS A FOLEY, BUT HOPES TO CATHETERIZE WITH A SOFTER PRODUCT IN THE FUTURE. EU STATED THAT THE CATHETER ACTUALLY LOOKED LIKE SHARP SPEARS. HE SAID THEY ARE LIKE LITTLE SPEARS.

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

  MAUDE report 7097279 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, END USER HAS HAD 4 UTIS IN THE LAST 6 MONTHS AND TRYING TO FIGURE OUT WHY. HE IS IN THE HOSPITAL RIGHT NOW AFTER RUNNING A FEVER AND CHILLS. THEY ARE DOING A CULTURAL RIGHT NOW. END USER WENT INTO BATHROOM TO CATH. EMPTIED THE RESIDUE FROM HIS CATH AND NOTICED IT WAS YELLOW AND IS ALARMED. I ASSURED HER THAT I AM NOT WORRIED. SHE ISN'T SURE IF THE CATHS SHE BROUGHT FROM HOME ARE FROM THE SAME BOX OR A NEW BOX THAT HE HAD BEEN USING. THE LOT# IS EITHER 4753627 OR 4753827. SHE IS GOING TO START PAYING ATTENTION OF HOW HE CATHS GOING FORWARD. HE USES GLOVES AND HE CLEANS THE AREA THOROUGHLY SO SHE IS SURE IT ISN'T ANYTHING HE IS DOING. IT'S THE SPEEDICATH COMPACT WHERE THE BAG IS NOT ATTACHED TO THE CATHETER. ADDITIONAL INFORMATION RECEIVED INDICATES THEY WERE AT THE DR'S OFFICE. END USER WAS HOSPITALIZED WITH A UTI FOR THE THIRD TIME IN 6 MONTHS. EACH TIME THE UTI IS A DIFFERENT STRAIN. THIS TIME HE WAS HOSPITALIZED WITH A KLEBSIELLA. THEY WENT BACK TO A CLOSED COLOPLAST CATHETER

  Patient problems: Urinary Tract Infection

  MAUDE report 6681597 ↗