SpeediCath Compact Set 28422Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708932967150), received between Oct 29, 2021 and Jan 7, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Material Split, Cut or Torn

  ACCORDING TO THE AVAILABLE INFORMATION, THIS INCIDENT CONCERNS AN EXPERIENCED END-USER WHO HAVE BEEN SELF-CATHETERISING FOR YEARS. WHEN THE INCIDENT HAPPENED, THE END-USER INSERTED AND DRAINED THE BLADDER AS NORMALLY. WHEN WITHDRAWING THE CATHETER, THERE WAS BLOOD ON THE CATHETER, AND THE TIP-PART WAS MISSING (THE PART THE TELESCOPES OUT). THE END-USER WENT TO THE ER, WHERE SURGERY WAS NEEDED TO REMOVE THE PART. THE END-USER WAS HOSPITALIZED FOR THREE DAYS, THERE WERE NO ADDITIONAL COMPLICATIONS, AND HE HAS BEEN INFORMED THAT THE DOCTOR EXPECTS HIM TO FULLY RECOVER. HE IS SELF-CATHETERIZING AGAIN, AFTER BEING EQUIPPED WITH A FOLEY CATHETER DURING THE HOSPITAL STAY. THE END-USER HAS NO UNDERLYING CONDITIONS AS STRICTURES OR ENLARGED PROSTATE. THE END-USER IS TRAINED IN USING THE CATHETER AND HE DID FOLLOW THE INSTRUCTIONS FOR USE (IFU). 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; Tissue Breakdown

  MAUDE report 23989467 ↗
• InjuryJan 9, 2025Separation Failure; Separation Failure

  ACCORDING TO THE AVAILABLE INFORMATION, THE COMPLAINT CONCERNS AN EXPERIENCED END-USER WHO HAVE BEEN PERFORMING SELF-CATHETERIZATION FOR 20 YEARS. THE END-USER HAD INSERTED THE SC COMPACT SET CATHETER TO EMPTY THE BLADDER WHEN PART OF THE DEVICE WAS DETACHED AND LEFT INSIDE THE URETHRA. THE END-USER EXPERIENCED PAIN AND BLEEDING AND WAS ADMITTED TO THE ER WHERE THE CATHETER PART WAS SURGICALLY REMOVED. THE END-USER SPENDS THE DAY IN THE ER BEFORE BEING DISCHARGED. THE FOLLOWING NIGHT, THE END-USER AGAIN EXPERIENCES PART OF THE CATHETER WAS LEFT IN THE BLADDER WHEN CATHETERIZING. THIS TIME, THE END-USER MANAGED TO EXTRACT THE CATHETER PART HIMSELF. THE TWO INCIDENCES OCCURRED FROM THE SAME BATCH ACCORDING TO THE END USER. THERE IS NO FURTHER INFORMATION AVAILABLE. 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; Pain; Urethral Stenosis/Stricture

  MAUDE report 21112585 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION AVAILABLE, THE REPORTS CONCERNS A (B)(6) MALE END-USER WHO CATHETERIZED APPROXIMATELY ONCE EVERY NIGHT. ON FIVE OCCASIONS THE END-USER WAS NOT ABLE TO DRAIN URINE. AT THE LAST CATHETERIZATION THERE WAS NO URINE BUT THERE WAS SOME BLEEDING, WHICH DIDN¿T PERSIST. THE NEXT MORNING ((B)(6) 2021) THE-END USER WAS CONFUSED, AND IN THE AFTERNOON, HE FELL AND HURT HIS HEAD. THE END-USER WAS THEN ADMITTED TO THE HOSPITAL DUE TO WEAKNESS. HE HAD A FEVER AND A URINARY TRACT INFECTION (UTI) AT ADMISSION (UTI, AND HE TESTED POSITIVE FOR KLEBSIELLA), BUT NO BLEEDING OR BLOOD INFECTION. HE WAS PLACED ON INDWELLING CATHETER AND ANTIBIOTICS. THE END-USER IS RECOVERING AND IS NOT PLANNING TO CONTINUE WITH INTERMITTENT CATHETERIZATION. THE WIFE PERFORMED THE CATHETERIZATIONS ACCORDING TO THE INSTRUCTION FOR USE (IFU), AND THEY DID NOT NOTICE ANY DAMAGE OR DEVIATIONS IN THE CATHETERS THEY USED. THE END-USER WAS ABLE TO CATHETERIZE DUE TO RESIDUAL URINE AND IS NEW TO INTERMITTENT CATHETERIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Hematuria; Urinary Tract Infection

  MAUDE report 12721358 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION AVAILABLE, THE REPORTS CONCERNS A (B)(6) YEAR-OLD MALE END-USER WHO CATHETERIZED APPROXIMATELY ONCE EVERY NIGHT. ON FIVE OCCASIONS THE END-USER WAS NOT ABLE TO DRAIN URINE. AT THE LAST CATHETERIZATION THERE WAS NO URINE BUT THERE WAS SOME BLEEDING, WHICH DIDN¿T PERSIST. THE NEXT MORNING (B)(6) 2021 THE-END USER WAS CONFUSED, AND IN THE AFTERNOON, HE FELL AND HURT HIS HEAD. THE END-USER WAS THEN ADMITTED TO THE HOSPITAL DUE TO WEAKNESS. HE HAD A FEVER AND A URINARY TRACT INFECTION (UTI) AT ADMISSION (UTI, AND HE TESTED POSITIVE FOR KLEBSIELLA), BUT NO BLEEDING OR BLOOD INFECTION. HE WAS PLACED ON INDWELLING CATHETER AND ANTIBIOTICS. THE END-USER IS RECOVERING AND IS NOT PLANNING TO CONTINUE WITH INTERMITTENT CATHETERIZATION. THE WIFE PERFORMED THE CATHETERIZATIONS ACCORDING TO THE INSTRUCTION FOR USE (IFU), AND THEY DID NOT NOTICE ANY DAMAGE OR DEVIATIONS IN THE CATHETERS THEY USED. THE END-USER WAS ABLE TO CATHETERIZE DUE TO RESIDUAL URINE AND IS NEW TO INTERMITTENT CATHETERIZATION. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Fall; Hematuria; Urinary Tract Infection

  MAUDE report 12721350 ↗