LoFric® Primo™ 41014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07333387043012), received between Mar 20, 2026 and Mar 20, 2026 — 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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Delivered as Unsterile Product

  THE ADVERSE EVENT OCCURRED OUTSIDE US, IN GREAT BRITAIN. ON (B)(6) 2026, A MALE PATIENT CONTACTED THE MANUFACTURER REPRESENTATIVE AND REPORTED THAT THE PRIMARY PACKAGE OF THE SINGLE-USE INTERMITTENT URINARY CATHETER LOFRIC PRIMO (40CM, CH14) WAS DAMAGED. WHEN THE WATER SACHET INSIDE THE PRIMARY PACKAGE WAS SQUEEZED, THE WATER PARTIALLY ESCAPED THROUGH A HOLE IN THE PRIMARY PACKAGE. 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 RECEIVED THREE DAMAGED PRODUCTS AND THAT HE HAD DISCARDED THESE THREE PRODUCTS WITHOUT USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647485 ↗