LoFric® Sense™ 4161250Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Sense Nelaton 15cm CH12 / Nelaton 6" 12FR · 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 07392532086366), received between Dec 20, 2017 and Dec 20, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Product Quality Problem” (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
- Product Quality Problem1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2017Product Quality Problem; Product Quality Problem
ACCORDING TO THE REPORTER, THE CATHETER WAS STUCK TO THE FOIL IN THE PACKAGE AND UPON REMOVAL FROM THE PACKAGE, THE FOIL WAS PHYSICALLY REMOVED. THE USER IS CONCERNED THAT THIS COULD BE LINKED WITH AN INFECTION, BUT DOES NOT WANT TO PROVIDE ANY FURTHER INFORMATION REGARDING THIS INCIDENT. IT IS NOT KNOWN WHETHER THE USE USED THE CATHETER OR NOT.
Patient problems: Unspecified Infection
MAUDE report 7132814 ↗
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