LoFric® Origo™ 44414 (REF 4441440)Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter with salt solution. LoFric Origo, Tiemann 40cm CH14 / Coudé 16" 14FR, 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 07392532122576), received between Jul 21, 2020 and Jul 21, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE COMPLAINT, AFTER USE OF THE CATHETER THERE WAS A URETHRAL BLEEDING, AND THE USER WENT TO THE HOSPITAL. INFORMATION OF THE EXTENT OF BLEEDING, IF ONLY MINOR OR MORE SEVERE , OR IF PATIENT WAS HOSPITALISED OR ONLY VISITED A CLINIC FOR ADVICE OR TREATMENT HAS NOT BEEN POSSIBLE TO GET INFORMATION ABOUT ALTHOUGH SEVERAL ATTEMPTS HAS BEEN MADE TO GET INFORMATION. THIS INCIDENT OCCURRED IN (B)(6).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 10300538 ↗
Other CATHETER, STRAIGHT devices
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- 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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