LoFric® Primo™ 41312Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Primo Nelaton 8" 12FR · Class 2
Data updated Oct 16, 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 07333387043098), received between Sep 30, 2024 and Sep 30, 2024 — classified as 1 malfunction.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
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.
MalfunctionSep 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
AN EXPERIENCED USER IN ITALY HAVE BEEN USING INTERMITTENT UROLOGY CATHETHERS FOR SEVERAL YEAR. THE AFFECTED PRODUCT, LOFRIC PRIMO, INCLUDES A WETTING SOLUTION BAG (SACHET) THAT IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE. THIS IS DONE BY SQUEEZING THE INTEGRATED BAG TO RELEASE THE WETTING SOLUTION WITH THE CATHETER IN ITS PACKAGE. ON AUGUST 2 THE USER DISCOVERED THAT THE PRODUCTS PRIMARY PACKAGE STERILE BARRIER WAS COMPROMISED WHEN THE SACHET WAS SQUEEZED TO ACTIVATE THE COATING OF THE CATHETER AND THE WETTING SOLUTION CAME OUT FROM THE SIDE OF THE CATHETER PACKAGE. SAME ERROR WAS DETECTED ON 30 CATHETERS WHICH WERE DISCARDED BY THE USER. THE CATHETERS WERE NOT USED, AND THERE WAS NO HARM OR CLINICAL IMPACT ON THE USER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20331846 ↗
Other Catheter, straight devices
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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