LoFric® Elle™ 4181425Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Elle Nelaton 10cm CH14 / Nelaton 4" 14FR 5-pack · Class 2
Data updated Oct 18, 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 07333387024530), received between Nov 13, 2024 and Nov 13, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A YOUNG WOMAN LOCATED IN (B)(6), NEWLY INTRODUCED TO INTERMITTENT CATHETERIZATION, USED A SINGLE USE, HYDROPHILIC, READY TO USE URINARY CATHETER (LOFRIC ELLE). USER HAD ONLY THE DAY BEFORE THE INCIDENT BEEN INSTRUCTED BY A HEALTHCARE PROFESSIONAL ON HOW TO PERFORM CATHETERIZATION HERSELF. USER INSERTED THE CATHETER INTO THE URETHRA AND EMPTIED THE BLADDER. WHEN THE USER WAS GOING TO REMOVE THE CATHETER FROM THE URETHRA, THE CATHETER COULD NOT BE REMOVED (PULLED OUT). USER TRIED SEVERAL TIME TO WITHDRAW THE CATHETER BUT WITH NO SUCCESS. AN EMERGENCY DOCTOR WAS CONTACTED AND ARRIVED AT THE WOMAN'S HOME 45 MINUTES LATER. THE EMERGENCY DOCTOR REMOVED THE CATHETER BY PUSHING THE CATHETER BACK INTO THE BLADDER BEFORE IT WAS REMOVED. THE REMOVED CATHETER WAS SLIGHTLY WET WITH BLOOD BUT HAD NO DAMAGES. USER WAS NOT HOSPITALIZED, AND NO FURTHER TREATMENT WAS NECESSARY. USER EXPERIENCED A BURNING PAIN IN THE URETHRA FOR 2 DAYS BEFORE IT RETURNED NORMAL. THE EMERGENCY DOCTOR HAD NO EXPLANATION ON WHY THE CATHETER WAS "STUCK" IN THE URETHRA BUT SPOKE OF THAT A "SUCTION" MAY HAVE OCCURRED. THE USER HAS AN INCOMPLETE SPINAL CORD INJURY AND WAS UNABLE TO CONFIRM THE QUESTION IF SPASTICITY MAY HAV
Patient problems: Pain
MAUDE report 20675052 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page