Skip to content

SpeediCath Compact Set 28522Recalls & reported problems

Coloplast A/S · SpeediCath Compact Set. Urinary catheter with attached bag for intermittent catheterization. Ready to use coated catheter. Nelaton. Female. Length: 3.5 in, Vol 750 ml. FR 12/4.0 mm. Rx only. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708932967136), received between Nov 7, 2016 and Nov 7, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Urinary Tract Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 7, 2016Patient-Device Incompatibility

    END USER CALLED IN AND SAID THE LAST 3X'S SHE USED THESE CATHETERS, SHE DEVELOPED A UTI WITHIN 2 DAYS OF USING THEM. END USER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED ANTIBIOTICS, WHICH CLEARED UP THE UTI. FURTHER INFORMATION: SHE GOT A UTI WITHIN 2 DAYS OF USING THE CATHETER THE LAST THREE TIMES SHE USED IT AND SHE WAS PRESCRIBED ANTIBIOTICS. SHE HAD 3 UTIS AND 3 TIMES ANTIBIOTICS. SHE SAID SHE DOES THE SAME PROCEDURE TO KEEP EVERYTHING CONSISTENT.

    Patient problems: Urinary Tract Infection

    MAUDE report 6083041 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.