Self-Cath 50454 / 416Recalls & reported problems
Coloplast A/S · No description. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 05708932999458), received between Mar 7, 2021 and Mar 7, 2021 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryMar 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS CASE INVOLVES A MALE PATIENT WHO STATED THAT HE RECENTLY HAD A SEVERE URINARY TRACT INFECTION (UTI) THAT REQUIRED HIM TO GO TO THE HOSPITAL. THE END-USER HAD EXPERIENCED UTIS BEFORE AND WAS FAMILIAR WITH USING INTERMITTENT CATHETERS. THE END-USER DID SEEK MEDICAL ATTENTION FOR THE UTI, BUT IT IS UNCLEAR WHETHER IT WAS HIS OWN DOCTOR, EMERGENCY ROOM OR ADMISSION TO THE HOSPITAL. NO INFORMATION ABOUT TREATMENT OR MEDICATION COULD BE OBTAINED. THE END-USER HAS FULLY RECOVERED WITH NO LASTING DAMAGE OR ISSUES. THE END-USER STATES THAT THERE WAS NOTHING WRONG WITH THE CATHETERS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 11426654 ↗
Other CATHETER, STRAIGHT devices
- Magic3 Go Male Catheter with SureGrip 53814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall490 reports
- Magic3 Go Male Coude Catheter with SureGrip 50814GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall3 deaths416 reports
- Magic3 Go™ Intermittent Urinary Catheter 51814C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall327 reports
- Magic3 Go Male Coude Catheter with SureGrip 50816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall239 reports
- Magic3 Go Male Catheter with SureGrip 53816GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall164 reports
- Magic3 Go Male Catheter with SureGrip 53812GC. R. Bard, Inc. · CATHETER, STRAIGHT1 recall120 reports
- Magic3 Go™ Intermittent Urinary Catheter 51812C. R. Bard, Inc. · CATHETER, STRAIGHT1 recall109 reports
- CURE CATHETER HM14Convatec, Purchasing Department · Catheter, Straight154 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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