LoFric® Origo™ 44410Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH10 / Coudé 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387043395), received between Mar 25, 2026 and Mar 25, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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
- Off-Label Use1
Patient problems
- Bacterial Infection1
- Hepatitis1
- Rheumatoid Arthritis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2026Off-Label Use
THE ADVERSE EVENT OCCURRED OUTSIDE US, IN SPAIN. THE (B)(6) HOSPITAL IN (B)(6) SPAIN, INDICATED US THAT THEY HAVE HAD AN INCREASE IN PROBLEMS WITH PATIENTS INSTILLED WITH BCG USING OUR CATHETERS, WHICH THEY STARTED BUYING IN 2025. THE CATHETERS USED ARE THE LOFRIC ORIGO TIEMANN MALE 40 CM (CH10 AND CH12); REF NUMBERS 4441000, 4441200 AND 4441280. BEFORE THE HOSPITAL USED TO USE ANOTHER MANUFACTURER'S PRODUCT, THE COLOPLAST NAVI. ACCORDING TO THE HOSPITAL THERE HAS BEEN A CONSIDERABLE INCREASE IN CASES OF BCGITIS SINCE THE SUMMER, IN TOTAL 3 CASES OF BCGITIS. THEY ALSO HAD 1 CASE OF HEPATITIS AND 1 CASE OF RHEUMATOID ARTHRITIS, WHICH BOTH REQUIRED HOSPITALIZATION. THIS DIDN'T HAPPEN TO THEM USING THE COLOPLAST NAVI CATHETERS. THE HOSPITAL HAS DECIDED TO PURCHASE AGAIN THE COLOPLAST NAVI CATHETERS FOR 3 MONTHS IN ORDER TO INVESTIGATE IF THE PROBLEMS DECREASE.
Patient problems: Bacterial Infection; Hepatitis; Rheumatoid Arthritis
MAUDE report 24686977 ↗
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