LoFric® 40314Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Nelaton 8" 14FR · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07392532135132), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sharp Edges” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Sharp Edges1
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.
MalfunctionAug 19, 2022Sharp Edges; Sharp Edges
THE INCIDENT CONCERN USAGE OF LOFRIC NELATON INTERMITTENT URINARY CATHETER WHICH OCCURRED IN AUSTRIA. PATIENT CLAIMED THAT SHE HAD USED LOFRIC 20 CM CATHETER NELATON (STRAIGHT TIP) FR 14 AND EXPERIENCED THAT THE CATHETER TIP WAS CATHETER TIP WAS ROUGH AND WAS CONSEQUENTLY INJURED. THE PATIENT CONSULTED MEDICAL CARE BECAUSE OF SORENESS AND BLEEDING. NO FURTHER INFORMATION HAS BEEN RECEIVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 15257615 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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