LoFric® Hydro-Kit™ 42516Recalls & reported problems
Wellspect AB · Single Use Urinary Catheter LoFric Hydro-Kit Coudé 16" 16FR · 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 07333387042961), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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, 2025Break; Break
THE ADVERSE EVENT OCCURRED OUTSIDE US, IN GERMANY. A MALE PATIENT HAS BEEN USING SEVERAL URINARY CATHETERS, LOFRIC HYDRO-KIT TIEMANN (40CM, CH16). LOFRIC HYDRO-KIT IS A STERILE, SINGLE USE, HYDROPHILIC CATHETER WITH SALT SOLUTION FOR ACTIVATION, INTENDED FOR INTERMITTENT URINARY CATHETERIZATION. IT HAS AN INTEGRATED URINE COLLECTION BAG (PRIMARY PACKAGE) AND IS READY TO USE ANYWHERE. THE WETTING SOLUTION IS USED TO ACTIVATE THE HYDROPHILIC CATHETER COATING BEFORE USE. ON (B)(6) 2025, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THERE WERE HOLES IN THE WELD SEAMS OF THE URINE COLLECTION BAGS FOR 10 OF THE PRODUCTS HE HAD USED. THE DEFECT IN THE URINE COLLECTION BAGS WAS DISCOVERED DURING USE AND THE URINE LEAKED ONTO THE PATIENT INSTEAD OF REMAINING IN THE URINE COLLECTION BAG. THE PATIENT REPORTED THAT HE FOUND ONE HOLE IN EACH URINE COLLECTION BAG. THE PATIENT WAS CAUSED NO HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22343792 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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