LoFric® Hydro-Kit™ 42012Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07333387042817), received between Mar 25, 2025 and Apr 21, 2026 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (2 reports).

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Delivered as Unsterile Product

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN CYPRUS. A MALE PATIENT HAS BEEN USING, A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETER LOFRIC HYDRO-KIT (40CM, CH12). ON MARCH 24TH, 2026, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT HE HAD RECEIVED THREE PRODUCTS WHERE THE PRIMARY PACKAGE WAS NOT SEALED COMPLETELY, IT HAD A HOLE AND WAS LEAKING. SINCE THE PRIMARY PACKAGE IS THE STERILE BARRIER OF THE PRODUCT, A HOLE IN THE PRIMARY PACKAGE IS COMPROMISING THE STERILE BARRIER OF THE PRODUCT. THE PATIENT REPORTED THAT HE HAD USED THE PRODUCTS AND THAT HE HAD DISCARDED THEM AFTER USE. THE PATIENT DID NOT SUFFER ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24940048 ↗
• MalfunctionOct 31, 2025Product Quality Problem; Tear, Rip or Hole in Device Packaging; Product Quality Problem; Tear, Rip or Hole in Device Packaging

  ADVERSE EVENT OCCURRED OUTSIDE US, IN ITALY. A MALE PATIENT HAS BEEN USING LOFRIC HYDRO-KIT NELATON (40CM, CH12) FOR 6 YEARS. ON OCTOBER 19, HE CONTACTED US TO LET US KNOW ABOUT SOME QUALITY ISSUES THAT HE HAD EXPERIENCED RECENTLY. ONE PRIMARY PACKAGE WAS MISSING THE CATHETER, AND ONE HAD A CATHETER WITH SALT RESIDUE ON IT. BOTH WHERE FROM THE SAME LOT. HE DID NOT USE THE CATHETERS, HE DISCARDED THEM AND USED OTHER ONES THAT HE HAD AT HIS DISPOSAL. HE DID HOWEVER SEND US SOME PICTURES. PATIENT REPORTED NO HEALTH IMPACT OR MEDICAL COMPLICATION. HE STATES THAT HE IS VERY HAPPY WITH THE PRODUCTS AND WILL CONTINUE TO USE LOFRIC HYDRO-KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435006 ↗
• MalfunctionAug 28, 2025Material Perforation; Material Integrity Problem; Material Perforation; Material Integrity Problem

  MALFUNCTION OF A DEVICE OCCURRED OUTSIDE THE US, IN ITALY. A MALE PATIENT HAS BEEN USING LOFRIC HYDRO-KIT NELATON (40CM, CH12) FOR 2 YEARS. ON (B)(6) 2025, THE PATIENT CONTACTED HIS CATHETER PROVIDER AND REPORTED THAT THERE HAD BEEN PROBLEMS WITH LEAKING PRODUCTS FOR THE LAST MONTHS. THERE HAD BEEN 3-4 CATHETERS PER BOX (30 CATHETERS IN ONE BOX) THAT HAD LEAKED SO ABOUT 20-30 IN TOTAL AND ALL FROM THE SAME LOT. THE URINE LEAKED OUT FROM THE URINE BAG AND ON TO HIS SHOES AND ON THE FLOOR. ALL FAULTY PRODUCTS HAVE BEEN DISCARDED. THE HOLE WAS LOCATED IN THE SAME PLACE ON ALL DEFECTED CATHETERS. THE PATIENT'S WISH WAS TO CONTINUE USING LOFRIC HYDRO-KIT AND REQUESTED AN EXTRA BOX TO BE ADDED TO HIS YEARLY SUPPLY, EXPECTED LATER IN AUGUST, TO COMPENSATE FOR THE ONES THAT LEAKED. 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. THE PATIENT DID NOT REPORT ANY HEALTH IMPACT OR MEDICAL COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22910885 ↗
• MalfunctionAug 6, 2025Break; Leak/Splash; Delivered as Unsterile Product; Break; Leak/Splash; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GERMANY. A MALE PATIENT HAS BEEN USING URINARY CATHETERS, LOFRIC HYDRO-KIT NELATON (40CM, CH12) FOR SEVERAL YEARS. 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 URINE COLLECTION BAGS FOR 4 OF THE PRODUCTS HE HAD USED. THE DEFECT IN URINE COLLECTION BAGS WAS DISCOVERED DURING USE AND THE URINE LEAKED OUT INSTEAD OF REMAINING IN THE URINE COLLECTION BAG. THE HOLE WAS LOCATED IN THE SAME PLACE ON ALL FOUR CATHETERS. NO INJURIES OR MEDICAL COMPLICATIONS HAVE BEEN REPORTED FOR THE PATIENT. HE WOULD LIKE TO CONTINUE USING LOFRIC HYDRO-KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22726421 ↗
• InjuryMar 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN (B)(6). A MALE PATIENT HAS BEEN USING, STERILE, SINGLE-USE INTERMITTENT URINARY CATHETERS, LOFRIC HYDRO-KIT NELATON (40CM, CH12). ON (B)(6) 2025, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT HE GETS PAIN AND BURNING ON THE PENIS IN CONNECTION WITH THE USE OF THE CATHETERS. THE PATIENT SUSPECTED AN ALLERGIC REACTION. THE PATIENT DID SEEK MEDICAL CARE ON (B)(6), AND TESTS MADE ON THE PATIENT REVEALED HE HAS ALLERGY TO SORBITAN SESQUIOLATE, SORBITAN OLEATE, LINALOOL AND SODIUM METABISULFITES. THE PATIENT WAS TREATED WITH AN INJECTION OF SPHINCTER TOXIN FOR RELAXING THE SPHINCTER. IN ADDITION TO THIS THE PATIENT ALSO HAS GOT A KNOWN ALLERGY TO PLASTIC OF TRANSPARENT DRESSINGS. THE PATIENT ALSO REPORTED THAT HE IS AFFECTED BY PAIN AND BURNING AFTER EACH CATHETERIZATION WITH ALL URINARY CATHETERS FROM ALL BRANDS. THE PATIENT REPORTED THAT HE CHOOSES CATHETERS FROM WELLSPECT HEALTHCARE BECAUSE HE IS LEAST AFFECTED BY THOSE CATHETERS. THE PATIENT HAS BEEN USING CATHETERS FOR 6 MONTHS TO 1 YEAR.

  Patient problems: Local Reaction

  MAUDE report 21686064 ↗