LoFric® Origo™ 44316 (REF 4431640)Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH16 / Nelaton 16" 16FR, Sterile device. · Class 2
All models of LoFric Origo (12)
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 07333387043357), received between Jul 7, 2025 and Jul 7, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Material Perforation” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Perforation1
Patient problems
- Fever1
- 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.
InjuryJul 7, 2025Material Perforation; Material Perforation
ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE. A 49-YEAR-OLD MAN WITH 3 YEARS OF EXPERIENCE USING LOFRIC ORIGO, A SINGLE USE HYDROPHILIC URINARY CATHETER INTENDED FOR INTERMITTENT CATHETERIZATION, WAS ADMITTED TO THE HOSPITAL 2 DAYS AFTER USING A NON-COMPLIANT LOFRIC ORIGO CATHETER. ON (B)(6), THE USER TOOK A CATHETER (LOFRIC ORIGO) TO PERFORM HIS CATHETERIZATION AS USUAL AND SQUEEZED THE BAG OF LIQUID FLUID IN THE PACKAGE TO ACTIVATE THE COATING ON THE CATHETER. HE NOTICED THAT LIQUID WAS LEAKING FROM THE PACKAGE BUT CONTINUED HIS CATHETERIZATION PROCEDURE. HE NOTED THAT IT WAS A LITTLE MORE DIFFICULT TO INSERT THE CATHETER BUT DID NOT THINK MUCH OF IT. AFTERWARDS, WHEN HE WAS GOING TO PUT THE CATHETER BACK IN ITS PACKAGE, HE DISCOVERED THAT THERE WAS LIQUID ON THE FLOOR. IT WAS AFTER THIS, WHEN WE WAS GOING TO THROUGH AWAY THE CATHETER, THAT HE SAW THAT THE PRIMARY PACKAGING HAD RED TAPE ON THE LOWER END OF THE PACKAGING AND THAT THE PACKAGING WAS NOT PROPERLY SEALED. THIS WAS NOTED ON 3 ADDITIONAL CATHETERS IN THE SAME CUSTOMER BOX AND LOT. THESE CATHETERS WERE NOT USED. ON (B)(6) HE HAD HIGH FEVER (40C) AND HEADACHE AND WAS ADMITTED TO THE HOSPITAL. USER WAS DIAGNOSED WITH A SEV
Patient problems: Fever; Urinary Tract Infection
MAUDE report 22410261 ↗
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.
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