ARTIA Reconstructive Tissue Matrix CS1097PRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M328CS1097P0), received between May 20, 2025 and Sep 10, 2025 — classified as 3 injuries.

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 3 most recent of 3 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). THIS EMDR IS BEING SUBMITTED FOR THE LOT # UP200128-112.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 23020090 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 04/21/2025, PMQA BECAME AWARE OF A CLINICAL STUDY IN THE USA REPORTING RIGHT BREAST ERYTHEMA, SWELLING AND PAIN. SITE NAME: (B)(6) SYSTEM. RELATIONSHIP TO STUDY DEVICE (ARTIA): NOT RELATED. RELATIONSHIP TO STUDY DEVICE PROCEDURE (ARTIA IMPLANTATION): NOT RELATED. PATIENT RECEIVED LEVAQUIN AND TORADOL AS PROPHYLACTIC TREATMENT. PATIENT HAS "ANXIETY AND WAS CONCERNED THAT THE SWELLING IN BREAST HAS INCREASED SINCE FOLLOW UP THE DAY PRIOR." PATIENT "WENT TO THE ER THE FOLLOWING DAY WITH CONCERNS OF WORSENING CONDITIONS. ER GAVE [THEM] MEDICATION TO HELP WITH DISCOMFORT UNTIL NEXT FOLLOW UP, BUT NO NEW SYMPTOMS WERE NOTED." THIS RECORD REPRESENTS 2 OUT OF 2 ARTIA PIECES (RELATED COMPLAINT NUMBER: (B)(6). ARTIA WAS REMOVED. "ARTIA HAD NOT ADHERED TO PATIENT AT ALL AND SEROMA WAS HEAVILY INFECTED. PI MADE THE DECISION TO REMOVE DEVICE ENTIRELY. SAE AND PROCEDURE DOCUMENTED. SHE HAS ANTIBIOTICS NOW." "PATIENT HAD ERYTHEMA AND DRAINAGE WHICH TESTED POSITIVE FOR KLEBSIELLA. CONDITIONS WORSENED FROM PREVIOUS AE." RELATIONSHIP TO ARTIA IS LISTED AS 'POSSIBLE.' ORGANISMS IDENTIFIED: KLEBSIELLA AEROGENES AND FINEGOLDIA MAGNA ON (B)(6) 2025. "INITIALLY WAS BREAST IRRIGATION WITH DEBRIDEMENT W

  Patient problems: Bacterial Infection; Seroma; Skin Inflammation/ Irritation

  MAUDE report 22054597 ↗
• InjuryMay 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 04/21/2025, PMQA BECAME AWARE OF A CLINICAL STUDY IN THE USA REPORTING RIGHT BREAST ERYTHEMA, SWELLING AND PAIN. RELATIONSHIP TO STUDY DEVICE (ARTIA): NOT RELATED. RELATIONSHIP TO STUDY DEVICE PROCEDURE (ARTIA IMPLANTATION): NOT RELATED. PATIENT RECEIVED LEVAQUIN AND TORADOL AS PROPHYLACTIC TREATMENT. PATIENT HAS "ANXIETY AND WAS CONCERNED THAT THE SWELLING IN BREAST HAS INCREASED SINCE FOLLOW UP THE DAY PRIOR." PATIENT "WENT TO THE ER THE FOLLOWING DAY WITH CONCERNS OF WORSENING CONDITIONS. ER GAVE [THEM] MEDICATION TO HELP WITH DISCOMFORT UNTIL NEXT FOLLOW UP, BUT NO NEW SYMPTOMS WERE NOTED." THIS RECORD REPRESENTS 1 OUT OF 2 ARTIA PIECES (RELATED COMPLAINT NUMBER CN-253258). ARTIA WAS REMOVED. "ARTIA HAD NOT ADHERED TO PATIENT AT ALL AND SEROMA WAS HEAVILY INFECTED. PI MADE THE DECISION TO REMOVE DEVICE ENTIRELY. SAE AND PROCEDURE DOCUMENTED. SHE HAS ANTIBIOTICS NOW." "PATIENT HAD ERYTHEMA AND DRAINAGE WHICH TESTED POSITIVE FOR KLEBSIELLA. CONDITIONS WORSENED FROM PREVIOUS AE." RELATIONSHIP TO ARTIA IS LISTED AS 'POSSIBLE.' ORGANISMS IDENTIFIED: KLEBSIELLA AEROGENES AND FINEGOLDIA MAGNA ON (B)(6) 2025. "INITIALLY WAS BREAST IRRIGATION WITH DEBRIDEMENT WHICH BECAME A FULL DEVI

  Patient problems: Bacterial Infection; Seroma; Skin Inflammation/ Irritation

  MAUDE report 22054450 ↗