LoFric® 40516Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Coudé 16" 16FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07392532131721), received between Nov 9, 2018 and Aug 28, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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
- Insufficient Device Problem Information2
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE LOFRIC CLASSIC URINARY CATHETER GOT STUCK WHEN THE PATIENT TRIED TO REMOVE IT AND THE END CAME OFF WHEN HE TRIED TO PULL IT OUT. THE CATHETER HAD TO BE EXTRACTED BY SURGERY.
Patient problems: Patient Problem/Medical Problem
MAUDE report 8938712 ↗InjuryNov 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, THE USER EXPERIENCED A BLEEDING DURING URINE CATHETERIZATION. ALSO, THE MARK AT THE END OF THE CATHETER WAS OFF. NO MEDICAL INTERVENTION REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 8054326 ↗
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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