LoFric® Hydro-Kit™ 42010Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Hydro-Kit Nelaton 16" 10FR · 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 07333387042800), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Delivered as Unsterile Product1
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.
MalfunctionJun 27, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
A 56-YEAR-OLD MALE USER DISCOVERED ON (B)(6) 2025, WHILE PREPARING FOR SELF-CATHETERIZATION, THAT THE CATHETER HE WAS GOING TO USE WAS NOT PACKED IN THE PRIMARY PACKAGING. IT WAS LOOSE OUTSIDE THE PRIMARY PACKAGING, INDICATING A COMPROMISED STERILE BARRIER. HE DID NOT USE THIS CATHETER. HE USED ANOTHER ONE FROM THE SAME CUSTOMER BOX. THERE WAS ONLY ONE CATHETER WITH THIS DEFECT IN THE CUSTOMER BOX, ALL OTHER CATHETERS WERE FINE. NO MEDICAL INJURY OR MEDICAL COMPLICATION WAS REPORTED. THE USER HAS OVER 10 YEARS OF EXPERIENCE USING INTERMITTENT CATHETERS AND HAS A SPINAL CORD INJURY, TRAUMATIC BRAIN INJURY, NEUROGENIC BLADDER INJURY, AND URINARY RETENTION. LOFRIC HYDRO-KIT IS A STERILE SINGLE USE, HYDROPHILIC CATHETER WITH SALT SOLUTION FOR ACTIVATION. IT HAS AN INTEGRATED URINE COLLECTION BAG AND IS READY TO USE ANYWHERE. THE WETTING SOLUTION IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE. PRIMARY PACKAGE (STERILE PACKAGE) IS PROTECTING THE CATHETER UNTIL USE. THE STERILE PACKAGE IS A URINE COLLECTION BAG WITH OPENING LOOPS FOR EASY TO ACCESS TO THE CATHETER. TO ENHANCE ASEPTIC HANDLING THERE IS A NON-TOUCH FUNCTION THAT ALLOWS CATHETERIZATION WITHOUT HAVING TO TOUC
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22345868 ↗
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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