ARTIA Reconstructive Tissue Matrix CM1097PRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI M328CM1097P0), received between Sep 10, 2025 and Sep 10, 2025 — classified as 1 injury.

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

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HEALTHCARE PROFESSIONAL REPORTED THAT A CLINICAL PATIENT THAT WAS IMPLANTED WITH ARTIA HAS EXPERIENCED INFECTED SEROMA IN THE LEFT BREAST. THE FOLLOWING ACTIONS HAVE BEEN TAKEN: SEROMA ASPIRATED FOR TURBID SEROMA, CULTURE SENT, AND SEROMA CATHETER PLACED. KEFLEX ORAL ANTIBIOTIC HAS BEEN GIVEN AS A TREATMENT. SYMPTOMS HAVE BEEN RESOLVED. IT WAS CONFIRMED LATER THAT BOTH LOT NUMBERS UP200128-112, AND UP200133-274 WERE USED ON THE LEFT BREAST IN THE ORIGINAL IMPLANT. THIS IS THE SAME PATIENT REPORTED UNDER PATIENT IDENTIFIER (B)(6) (EMDR-(B)(4). THIS EMDR IS BEING SUBMITTED FOR THE LOT # UP200133-274.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 23020213 ↗