Self-Cath 50474 / 814Recalls & 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 05708932999670), received between Aug 11, 2016 and Aug 11, 2016 — classified as 1 injury.
The most frequently reported specific device problem is “Bent” (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
- Bent1
- Crack1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2016Bent; Crack
ACCORDING TO THE AVAILABLE INFORMATION, END-USER HAD A DAMAGED PRODUCT. END-USER DOES NOT THINK THAT ANY OF THE CATHETER REMAINS IN HIM. APPEARANCE OF A CRACK IN THE CATHETER NEAR THE BEND AND A BARB LIKE PROJECTION MAKING THE WITHDRAWAL PAINFUL. THE BLEEDING HAS SUBSIDED AND HAS A DOCTOR'S APPOINTMENT NEXT MONTH. ADVISED TO SEEK MEDICAL ATTENTION IMMEDIATELY IF ANY FURTHER ISSUES ARISE AND HE HAS AGREED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 5870179 ↗
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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