Self-Cath 50463 / 214Recalls & 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 05708932999922), received between Aug 11, 2022 and Aug 11, 2022 — 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.
InjuryAug 11, 2022Patient-Device Incompatibility; Patient-Device Incompatibility
ACCORDING TO THE AVAILABLE INFORMATION, THIS CASE INVOLVES A FEMALE PATIENT WHO STATES PRIOR TO HER LAST ORDER OF COLOPLAST CATHETERS, SHE JUST HAD A UTI AND IS CONVINCED THAT IT WAS FROM COLOPLAST CATHETERS. THE UTI PLACED HER IN HOSPITAL, BUT IT WAS NOT REPORTED IF INTERVENTION WAS REQUIRED OR WHAT KIND OF TREATMENT WAS RECEIVED. SHE HAS BEEN ADVISED THAT THERE COULD BE MANY VARIOUS REASONS FOR THE DEVELOPMENT OF UTI'S AND THAT SHE SHOULD BE SPEAKING TO HER DOCTOR FOR TREATMENT PLANS OR DIFFERENT MEDICATIONS THAT SHE COULD POTENTIALLY TAKE TO HELP PREVENT THEM. ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER, BUT NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: Urinary Tract Infection
MAUDE report 15209202 ↗
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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