LoFric® 40018Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Nelaton 16" 18FR · Class 2
Data updated Oct 13, 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 07392532131813), received between May 3, 2022 and May 3, 2022 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- 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.
MalfunctionMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CUSTOMER REPORTED MODERATE BLEEDING FROM CATHETER USAGE AND TO REQUEST A DIFFERENT FRENCH SIZE. OUR CLINICAL NURSE, REACHED OUT TO THE PATIENT AND LEARNED HE WASN'T ACTIVATING LOFRIC CLASSIC (DRY CATHETER) PROPERLY. HE WAS USING A GEL LUBRICANT AND NOT SOAKING FOR 30 SECONDS WITH WATER ACCORDING TO PROVIDED INSTRUCTIONS FOR USE. HE WAS ALSO USING 18FR SAMPLES HE HAD LEFTOVER AT HOME. HIS REGULAR SHIPMENT IS FOR 16FR. HE SAID HE PREFERS USING A LOFRIC CATHETER WITH LUBRICANT (SALINE SOLUTION). WELLSPECT CUSTOMER SERVICE EMAILED THE PATIENT PRODUCT CATALOG, IFUS, MEN'S GUIDE AND INSTRUCTIONAL VIDEOS TO HELP HIM FIGURE IT OUT. THE PATIENT WAS ENCOURAGED TO CONTACT CUSTOMER SERVICE IF HE HAD ANY QUESTION ABOUT PRODUCT USAGE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Urinary Tract Infection
MAUDE report 14268178 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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