LoFric® Primo™ 41012Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07333387043005), received between Oct 17, 2024 and Oct 22, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. A PATIENT REPORTED ON (B)(6) 2025, THAT SEVERAL DEVICES WERE RECEIVED BY THE PATIENT WITH BROKEN PRIMARY PACKAGING SEAL, COMPROMISING THE STERILE BARRIER OF THE DEVICE. THE DEVICE IS A STERILE, SINGLE-USE INTERMITTENT URINARY CATHETER, LOFRIC PRIMO NELATON MALE 40CM CH12. PRODUCTS WITH TWO DIFFERENT LOT NUMBERS WERE INVOLVED. LOT: 664407, MANUFACTURING DATE: 17 JANUARY 2025, EXPIRY DATE: 17 JULY 2028, LOT: 669391, MANUFACTURING DATE: 13 JUNE 2025, EXPIRY DATE: 11 DECEMBER 2028, IT IS UNKNOWN IF THE PATIENT USED ANY OF THE DEVICES. NO HARM IS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355811 ↗
• MalfunctionOct 31, 2024Break; Break

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN (B)(6). THE DEVICE 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. WHEN THE USER SQUEEZED THE SACHET TO ACTIVATE THE COATING OF THE CATHETER, THE WETTING SOLUTION CAME OUT FROM THE SIDE OF THE CATHETER PACKAGE, INDICATING THAT THE PACKAGE'S STERILE BARRIER WAS COMPROMISED. 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 20579971 ↗
• MalfunctionOct 17, 2024Break; Product Quality Problem; Break; Product Quality Problem

  ADVERSE EVENT OCCURRED OUTSIDE US, IN ITALY. 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. WHEN THE PATIENT SQUEEZED THE SACHET TO ACTIVATE THE COATING OF THE CATHETER, THE WETTING SOLUTION CAME OUT FROM THE SIDE OF THE CATHETER PACKAGE, INDICATING THAT THE PACKAGE'S STERILE BARRIER WAS COMPROMISED. THIS OCCURRED WITH 60 CATHETERS. THE CATHETERS WERE NOT USED, AND THERE WAS NO HARM OR CLINICAL IMPACT ON THE USER. THE PATIENT COULD PERFORM THE INTERMITTENT CATHETERIZATION (IC) USING PRODUCTS FROM ANOTHER BOX. THE PATIENT HAS BEEN CATHETERISING WITH THE SAME CATHETER FOR SEVERAL YEARS AND HAS NEVER EXPERIENCED ANY PROBLEMS BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20469259 ↗