LoFric® Origo™ 44310Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter with salt solution. LoFric Origo, Nelaton 40cm CH10 / Nelaton 16" 10FR, 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387043296), received between Apr 25, 2024 and Apr 25, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (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
- Defective Device1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2024Product Quality Problem; Defective Device; Product Quality Problem; Defective Device
EVENT OCCURED IN UNITED KINGDOM, I.E. OUTSIDE USA. THE PATIENT HAD BEEN PERFORMING INTERMITTENT SELF CATHETERIZATION (ISC) FOR 2.5 YEARS WITHOUT ANY PROBLEM. AT ONE OCCASION, WHILE INSERTING THE CATHETER TUBE IN TO THE URETHRA, HE NOTICED A NOTCH ON THE UPPER HALF OF THE CATHETER TUBE, ABOUT 6.5 CM FROM THE FUNNEL. HE STOPPED INSERTING THE CATHETER AND WITHDREW IT INSTEAD, BEFORE THE NOTCH ENTERED THE URETHRA. NO INJURY REPORTED. THE PATIENT USED THE OTHER PRODUCTS IN THE BOX, AND THEY HAD NO DEFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19179412 ↗
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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