LoFric OrigoRecalls & reported problems across all models

We found 12 models of LoFric Origo by Wellspect AB in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Jan 8, 2018 and Mar 25, 2026 — classified as 20 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported LoFric Origo problems

LoFric Origo models

12 models, most reported first. Each model has its own page with its reports, recalls and device details.

• LoFric® Origo™ 44314

  Catheter, straight
  5 reports
• LoFric® Origo™ 44312

  CATHETER, STRAIGHT
  4 reports
• LoFric® Origo™ 44312

  Catheter, straight
  3 reports
• LoFric® Origo™ 44414

  Catheter, straight
  3 reports
• LoFric® Origo™ 44416

  Catheter, straight
  2 reports
• LoFric® Origo™ 44416

  CATHETER, STRAIGHT
  2 reports
• LoFric® Origo™ 44314

  CATHETER, STRAIGHT
  2 reports
• LoFric® Origo™ 44310

  Catheter, straight
  1 report
• LoFric® Origo™ 44316

  Catheter, straight
  1 report
• LoFric® Origo™ 44410

  Catheter, straight
  1 report
• LoFric® Origo™ 44316

  CATHETER, STRAIGHT
  1 report
• LoFric® Origo™ 44414

  CATHETER, STRAIGHT
  1 report

Recent LoFric Origo adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Off-Label Use

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN SPAIN. THE (B)(6) HOSPITAL IN (B)(6) SPAIN, INDICATED US THAT THEY HAVE HAD AN INCREASE IN PROBLEMS WITH PATIENTS INSTILLED WITH BCG USING OUR CATHETERS, WHICH THEY STARTED BUYING IN 2025. THE CATHETERS USED ARE THE LOFRIC ORIGO TIEMANN MALE 40 CM (CH10 AND CH12); REF NUMBERS 4441000, 4441200 AND 4441280. BEFORE THE HOSPITAL USED TO USE ANOTHER MANUFACTURER'S PRODUCT, THE COLOPLAST NAVI. ACCORDING TO THE HOSPITAL THERE HAS BEEN A CONSIDERABLE INCREASE IN CASES OF BCGITIS SINCE THE SUMMER, IN TOTAL 3 CASES OF BCGITIS. THEY ALSO HAD 1 CASE OF HEPATITIS AND 1 CASE OF RHEUMATOID ARTHRITIS, WHICH BOTH REQUIRED HOSPITALIZATION. THIS DIDN'T HAPPEN TO THEM USING THE COLOPLAST NAVI CATHETERS. THE HOSPITAL HAS DECIDED TO PURCHASE AGAIN THE COLOPLAST NAVI CATHETERS FOR 3 MONTHS IN ORDER TO INVESTIGATE IF THE PROBLEMS DECREASE.

  Patient problems: Bacterial Infection; Hepatitis; Rheumatoid Arthritis

  MAUDE report 24686977 ↗
• InjuryFeb 9, 2026Product Quality Problem; Patient Device Interaction Problem

  MALE PATIENT, THAT HAS BEEN USING CATHETERS FOR A LONG TIME. RECENTLY SWITCHED FROM STRAIGHT TIP TO COUDE TIP. RECENTLY HE HAD TWO EPISODES OF BLEEDING, THE TWO EPISODES HAPPENED WITHIN TWO WEEKS TIME. THE FIRST BLEEDING LASTED A DAY AND SELF RESOLVED. THE SECOND TIME, THE PATIENT EXPERIENCED BLEEDING DURING EACH TIME HE CATHETERIZED DURING FOUR DAYS STRAIGHT, ONLY DURING CATHETERIZATION, NOT BEFORE OR AFTER. ON THE FOURTH DAY, WHICH WAS JANUARY 25TH, THE PATIENT WENT TO URGENT CARE. THE BLEEDING HAD THEN RESOLVED AND NO BLEEDING HAS OCCURED SINCE. WHEN HE WENT TO URGENT CARE, HE ALSO EXPERIENCED FEVER AND IRREGULAR HEART RATE. HE WAS DIAGNOSED WITH UTI AND TREATED WITH IV ANTIBIOTICS. ON JANUARY 30TH THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. HE SAYS THAT HIS BLOOD PRESSURE IS OKEY NOW AND THAT HE IS FEELING OKEY BUT NOT GREAT. PATIENT WANTS TO SWITCH TO ANOTHER CATHETER BRAND. THE PATIENT DESCRIBED THE CATHETER TIP AS TOO SHARP AND THAT IT SCRATCHES THE URETHRA. HE SAYS THIS WAS A GENERAL COMPLAINT ABOUT THE COUDE TIP AND NOT SPECIFIC FOR ANY BATCH. ALSO, HE MENTIONED THAT THE COUDE INDICATOR RIDGE IS OFFSET AND THAT IT IS HARD TO REMEMBER TO CHECK THE SPECIFIC ORIENTATION. TH

  Patient problems: Genital Bleeding; Urinary Tract Infection

  MAUDE report 24290016 ↗
• InjuryDec 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS ADVERSE EVENT OCCURRED IN THE USA. A MALE PATIENT WITH THE MEDICAL CONDITION URINARY RETENTION, BPH, CONSTIPATION AND DIABETES, HAS BEEN USING A STERILE, SINGLE-USE, INTERMITTENT URINARY CATHETER, LOFRIC ORIGO COUDÉ (16'' 16FR). ON (B)(6) 2025, THE PATIENT INFORMED THE MANUFACTURER REPRESENTATIVE THAT HE HAD AN INCIDENT WITH THE CATHETER 2 DAYS AGO. THE PATIENT, WHO IS NEW TO THE THERAPY INTERMITTENT CATHETERIZATION, HAD PROBLEMS INSERTING THE CATHETER AND HE EXPERIENCED IT VERY RESISTANT TO INSERT. HE STATED HE DID EXPERIENCE PAIN WHEN HE MET THE RESISTANCE. AFTER HE HAD REMOVED THE CATHETER, SEVERE BLEEDING OCCURRED (PROBABLY A FRUIT JUICE GLASS SIZE OF BLOOD, ACCORDING TO THE PATIENT). THE PATIENT WENT TO THE HOSPITAL EMERGENCY DUE TO THE BLEEDING. HE STATED THAT THE HOSPITAL PLACED A FOLEY CATHETER AND TOLD HIM THAT HIS PROSTATE WAS SWOLLEN AND "PINCHED OFF THE URETHRA." HE WAS THEN RELEASED HOME. THE ONLY TREATMENT HE HAD WAS A FOLEY CATHETER INSERTED. HE STATED HE WILL HAVE THE FOLEY UNTIL ON (B)(6) AS THAT'S THE SOONEST THE UROLOGIST COULD SEE HIM. THE MANUFACTURER REPRESENTATIVE PROVIDED EDUCATION FOR IC TECHNIQUE, WAYS TO RELAX THE SPHINCTER AND EASE THE CATHETER IN,

  Patient problems: Inflammation

  MAUDE report 23776510 ↗
• InjuryNov 11, 2025Break; Material Separation; Break; Material Separation

  AN ADVERSE EVENT OCCURRED IN THE US WHERE A YOUNG 18-YEAR-OLD WOMAN REPORTED THAT WHILE SHE WAS SELF-CATHETERIZING WITH A LOFRIC ORIGO INTERMITTENT CATHETER, IT BROKE INSIDE HER BODY. THE USER NOTICED WHEN SHE PULLED OUT THE CATHETER THAT SOMETHING WAS WRONG WITH IT BECAUSE THE CATHETER TIP WAS MISSING, THE CATHETER WAS BROKEN. SHE INITIALLY THOUGHT THAT THE CATHETER TIP MIGHT HAVE FALLEN TO THE FLOOR, BUT IT HAD NOT. THE USER VISITED HER UROLOGIST THE SAME DAY (APPROXIMATELY 2 HOURS LATER) AND HAD A CYSTOSCOPY PERFORMED WHICH REVEALED THE CATHETER TIP IN THE USER'S BLADDER. IT WAS REMOVED IN THE UROLOGIST'S OFFICE (WITHOUT SURGERY) AND THE USER WAS ABLE TO GO HOME WITHOUT ANY ANTIBIOTIC PRESCRIPTIONS. THE USER EXPERIENCED SOME TENDERNESS AND PAIN THE FOLLOWING DAY. ACCORDING TO THE USER'S GRANDMOTHER, THE CATHETER DID NOT LOOK DIFFERENT, AND THE CATHETER PACKAGING LOOKED UNOPENED. THE USER PERFORMED THE CATHETERIZATION AS INSTRUCTED, SQUEEZING THE WATER BAG (SACHET) BEFORE USE TO ACTIVATE THE CATHETER COATING. PER HER GRANDMOTHER SHE DID NOT USE ANY SHARP TOOLS (SCISSORS ETC) ON THE CATHETER OR PACKAGING. THE USER IS NEW TO CIC (CLEAN INTERMITTENT CATHETERIZATION). SHE PERFORMED C

  Patient problems: Foreign Body In Patient

  MAUDE report 23521041 ↗
• MalfunctionSep 11, 2025Break; Leak/Splash; Delivered as Unsterile Product; Break; Leak/Splash; Delivered as Unsterile Product

  ADVERSE EVENT OCCURRED OUTSIDE US, IN SWITZERLAND. ON JULY 17TH 2025, THE MANUFACTURER GOT THE INFORMATION THAT THE WATER SACHET INCLUDED IN THE PRIMARY PACKAGE HAD A WEAK SEAL AND THAT THE WATER SPRAYED OUT. THE FAULT WAS OBSERVED PRIOR TO USE. NO FURTHER INFORMATION AND NO PHOTOS WHERE AVAILABLE. UP ON ARRIVAL OF PRODUCTS RETURNED BY THE USER ON AUGUST 29TH, IT WAS MADE CLEAR THAT THE WELD OF THE PRIMARY PACKAGE WAS DAMAGED, HENCE COMPROMISING THE STERILE BARRIER, THIS DAY IS THE MANUFACTURER AWARENESS DATE OF REPORTABILITY. THE PATIENT DID NOT USE THE CATHETERS AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025041 ↗
• InjuryJul 7, 2025Material Perforation; Material Perforation

  ADVERSE EVENT OCCURRED OUTSIDE US, IN FRANCE. A 49-YEAR-OLD MAN WITH 3 YEARS OF EXPERIENCE USING LOFRIC ORIGO, A SINGLE USE HYDROPHILIC URINARY CATHETER INTENDED FOR INTERMITTENT CATHETERIZATION, WAS ADMITTED TO THE HOSPITAL 2 DAYS AFTER USING A NON-COMPLIANT LOFRIC ORIGO CATHETER. ON (B)(6), THE USER TOOK A CATHETER (LOFRIC ORIGO) TO PERFORM HIS CATHETERIZATION AS USUAL AND SQUEEZED THE BAG OF LIQUID FLUID IN THE PACKAGE TO ACTIVATE THE COATING ON THE CATHETER. HE NOTICED THAT LIQUID WAS LEAKING FROM THE PACKAGE BUT CONTINUED HIS CATHETERIZATION PROCEDURE. HE NOTED THAT IT WAS A LITTLE MORE DIFFICULT TO INSERT THE CATHETER BUT DID NOT THINK MUCH OF IT. AFTERWARDS, WHEN HE WAS GOING TO PUT THE CATHETER BACK IN ITS PACKAGE, HE DISCOVERED THAT THERE WAS LIQUID ON THE FLOOR. IT WAS AFTER THIS, WHEN WE WAS GOING TO THROUGH AWAY THE CATHETER, THAT HE SAW THAT THE PRIMARY PACKAGING HAD RED TAPE ON THE LOWER END OF THE PACKAGING AND THAT THE PACKAGING WAS NOT PROPERLY SEALED. THIS WAS NOTED ON 3 ADDITIONAL CATHETERS IN THE SAME CUSTOMER BOX AND LOT. THESE CATHETERS WERE NOT USED. ON (B)(6) HE HAD HIGH FEVER (40C) AND HEADACHE AND WAS ADMITTED TO THE HOSPITAL. USER WAS DIAGNOSED WITH A SEV

  Patient problems: Fever; Urinary Tract Infection

  MAUDE report 22410261 ↗
• InjuryJun 26, 2025Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem; Manufacturing, Packaging or Shipping Problem; Patient Device Interaction Problem

  ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. MALE PATIENT REPORTED THAT 5-6 OF HIS CATHETERS RECENTLY FELT LIKE THEY HAD SHARP RIDGES ON THEM. AFTER USING ONE OF THE CATHETERS, HE DISINFECTED IT AND EXAMINED IT BY HAND. HE DESCRIBES THAT HE COULD FEEL LIKE A "CHISEL MARK". ON TWO OCCASIONS HE EXPERIENCED MINOR BLEEDING AFTER USING CATHETERS THAT HE PERCEIVED AS SHARP. HE DID NOT SEEK ANY MEDICAL ATTENTION AND HAS RECOVERED WELL.

  Patient problems: Genital Bleeding

  MAUDE report 22335863 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT WAS SENT A URINARY CATHETER OF THE WRONG SIZE (SMALLER THAN REQUIRED WITH A CURVED TIP) BY MISTAKE. PATIENT DISCOVERED THE MISTAKE AND REQUESTED AN EXPEDITE OF THE CORRECT CATHETER. THE USE OF WRONG CATHETER LED TO A MINOR BLEEDING AND PATIENT VISITED THE ER TO HAVE THIS CHECKED OUT. EVERYTHING WAS FINE AND PATIENT HAS RECOVERED. THE ERROR OCCURRED AT THE DISTRIBUTION LEVEL OF THE LOCAL WHOLESALER, WHERE THEY MIS-PICKED THE WRONG CATHETER TYPE AND SHIPPED IT TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21917255 ↗
• MalfunctionFeb 7, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  PRODUCT PROBLEM OCCURRED OUTSIDE US, IN THE NETHERLANDS. A MALE USER OF LOFRIC ORIGO TIEMANN 40CM CH14 (STERILE SINGLE-USE INTERMITTENT URINARY CATHETER) DISCOVERED PRIOR TO USE THAT THE PRIMARY PACKAGE OF THE CATHETER WAS DAMAGED. THE PRIMARY PACKAGE (STERILE BARRIER) HAD A MISSING WELD AT THE LOWER END OF THE PACKAGING. THE PRODUCT WERE NOT USED AND NO HARM OR MEDICAL COMPLICATION WERE REPORTED. SEVERAL ATTEMPTS TO CONTACT USER HAVE BEEN MADE TO GATHER FURTHER INFORMATION ABOUT THE MALFUNCTION OF THIS DEVICE BUT WITH NO RESULT. THE AFFECTED CATHETERS WAS RETURNED TO MANUFACTURER FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331894 ↗
• MalfunctionJan 9, 2025Device Handling Problem; Device Handling Problem

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN UNITED KINGDOM. A MALE PATIENT HAS BEEN USING, A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETER LOFRIC ORIGO NELATON (40 CM, CH14). ON (B)(6) 2024, THE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT HE HAD PROBLEMS TO GET THE DEVICE OUT OF THE PACKAGING SINCE THE DEVICE WAS STUCK IN THE PACKAGE. THE PATIENT ALSO REPORTED THAT HE HAS GOT AN INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 21109566 ↗
• MalfunctionJan 9, 2025Product Quality Problem; Product Quality Problem

  A 73-YEAR-OLD MAN HAS BEEN USING LOFRIC ORIGO WITH TIEMANN (COUDE) TIP DUE TO PROBLEMS WITH URINARY RETENTION (NEUROGENIC BLADDER) AS WELL AS ENLARGED PROSTATE. THE USER EXPERIENCED BLOOD IN THE URINE AND ON THE TIP OF THE CATHETER AFTER USE. HE SOUGHT MEDICAL ATTENTION AND HAD A URINE CULTURE DONE TO DETERMINE THE BACTERIA COUNT. TO TREAT A URINARY TRACT INFECTION (UTI), HE WAS PRESCRIBED ANTIBIOTICS 3 TIMES DAILY FOR 14 DAYS. IN ADDITION, HE WILL TAKE LOW DOSE ANTIBIOTIC 1 TIMES DAILY INDEFINITELY TO FURTHER REDUCE RISKS OF UTI'S. NO OTHER TESTING, PROCEDURES, OR TREATMENTS WERE PERFORMED. ACCORDING TO THE PATIENT THE HARM IS RELATED DUE TO MISALIGNMENT BETWEEN THE CATHETER BENT TIP AND THE INDICATOR ON THE CATHETER FUNNEL WHICH HAS SCORED HIS URETHRA AND LET TO UTI.

  Patient problems: Urinary Tract Infection

  MAUDE report 21109464 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A 72-YEAR-OLD MAN WITH AN ENLARGED PROSTATE HAD PREVIOUSLY USED THE UROLIFT SYSTEM, A NON-INVASIVE TREATMENT FOR BPH THAT HELPS REDUCE PROSTATE SWELLING AND IMPROVE URINE FLOW. HE REQUIRED INTERMITTENT CATHETERIZATION (IC) ALONGSIDE THIS PROCEDURE. ON (B)(6) 2024, THE PATIENT INFORMED THE MANUFACTURER THAT HE HAD ENCOUNTERED "BURS" AT THE TIP OF THE CATHETERS ON TWO OCCASIONS. THE FIRST TIME HE NOTICED A "BUR," HE DISCARDED THE CATHETER AND USED A NEW ONE. THE SECOND TIME, HE DID NOT NOTICE THE "BUR" BECAUSE IT WAS NIGHTTIME. WHILE CATHETERIZING THAT NIGHT, HE FELT RESISTANCE AND HAD A STRONG URGE TO URINATE, SO HE "PUSHED HARDER," WHICH CAUSED BLEEDING. HE WENT TO THE EMERGENCY ROOM AT THE (B)(6) HOSPITAL AND WAS ADMITTED FOR 4 OR 5 DAYS. DURING HIS HOSPITAL STAY, THEY PERFORMED A PROCEDURE TO REMOVE THE UROLIFT AND STOP THE BLEEDING. HE MENTIONED THAT HE WAS "OUT OF IT" DURING HIS STAY. THE HOSPITAL ADVISED HIM TO STOP USING LOFRIC CATHETERS AND PROVIDED ALTERNATIVE CATHETERS. ACCORDING TO THE PATIENT, DUE TO THIS INCIDENT AND THE DAMAGE CAUSED BY THE CATHETER, HE WILL NOW HAVE TO SELF-CATHETERIZE FOR THE REST OF HIS LIFE. HE ALSO STATED THAT HIS HEALTHCARE PROVIDER NEVER PROVIDE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20682238 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MALE PATIENT REPORTED BLEEDING FOR SEVERAL DAYS AFTER USING INTERMITTENT URINARY CATHETER (LOFRIC ORIGO). HE IS AN EXPERIENCED USER AND HAS USED LOFRIC ORIGO DURING SEVERAL YEARS. STARTING AROUND (B)(6) 2024 PATIENT HAVE HAD A FEW BOUTS OF BLEEDING PROBABLY DUE TO ROUGH EDGES AROUND THE CATHETER HOLE ACCORDING TO THE PATIENT HIMSELF. THE LAST BOUT OF BLEEDING LASTED OVER FOUR DAYS. THE PATIENT ALSO CLAIMS THAT THE COATING OF THE CATHETER IS NOT A "SLIPPERY" AS IT HAS BEEN IN THE PAST. URINALYSIS AND URINE CULTURES HAS BEEN PERFORMED, ORDERED BY PATIENT'S UROLOGIST. BOTH WERE NEGATIVE. LAST BLEEDING, WHICH WAS MODERATE, LASTED FOR 4 DAYS. AT THAT TIME, PATIENT VISITED HIS UROLOGIST'S OFFICE AND URINALYSIS AND AN URINE CULTURE WAS PERFORMED. BOTH WERE NEGATIVE AND NO OBSTRUCTIONS WAS DETECTED IN URETHRA. AFTER EXAIMINATION THE PATIENT WAS GIVEN NEW CATHETER SAMPLES OF A DIFFERENT BRAND TO TRY.

  Patient problems: Genital Bleeding

  MAUDE report 19631439 ↗
• MalfunctionApr 25, 2024Product Quality Problem; Defective Device; Product Quality Problem; Defective Device

  EVENT OCCURED IN UNITED KINGDOM, I.E. OUTSIDE USA. THE PATIENT HAD BEEN PERFORMING INTERMITTENT SELF CATHETERIZATION (ISC) FOR 2.5 YEARS WITHOUT ANY PROBLEM. AT ONE OCCASION, WHILE INSERTING THE CATHETER TUBE IN TO THE URETHRA, HE NOTICED A NOTCH ON THE UPPER HALF OF THE CATHETER TUBE, ABOUT 6.5 CM FROM THE FUNNEL. HE STOPPED INSERTING THE CATHETER AND WITHDREW IT INSTEAD, BEFORE THE NOTCH ENTERED THE URETHRA. NO INJURY REPORTED. THE PATIENT USED THE OTHER PRODUCTS IN THE BOX, AND THEY HAD NO DEFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19179412 ↗
• MalfunctionFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT USER (PATIENT) REPORTED THAT 3 URINARY CATHETERS FROM THE SAME BOX HAD A CUT AT THE LOWER PART OF THE SINGLE STERILE PACKAGE. PATIENT CLAIMED, WHEN HE ACTIVATED THE WATER SACHET FOR WETTING OF THE HYDROPHILIC SURFACE, THE FLUID FLUSHED OUT ON THE FLOOR. IT IS LIKE A SMALL PART OF THE PACKAGE HAS BEEN CUT OFF. THE PATIENT USED TWO OF THE CATHETERS WITH THE SAME FAULT BUT DIDN'T EXPERIENCE ANY PROBLEMS DURING CATHETERIZATION OR AFTERWARDS. HE DID NOT GET A UTI OR ANY OTHER MEDICAL ISSUES DUE TO THIS AND REPORTS THAT HE IS DOING FINE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18737480 ↗