EluPro Antibiotic-Eluting BioEnvelope CMCV-124-MEDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00859389005331), received between Aug 28, 2025 and Jun 24, 2026 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  NOTIFICATION WAS RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT A (B)(6) YR. OLD MALE PATIENT WAS IMPLANTED WITH AN ABBOTT DUAL CHAMBER CIED ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-MED; LOT #M26C1093). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A LARGE DRAINING SEROMA (SPECIFIC DATE IS UNKNOWN) THAT REQUIRED THE PHYSICIAN TO PERFORM A POCKET EVACUATION - REMOVAL OF THE ELUPRO BIOENVELOPE AND CLOT(S), ON (B)(6) 2026. SURROUNDING TISSUE WAS DESCRIBED AS RED WITH POSSIBLE GRANULATION, CULTURES WERE TAKEN AT THE TIME OF THE POCKET EVACUATION BUT WERE NEGATIVE FOR ANY BACTERIA. THE ELUPRO BIOENVELOPE WASN'T COMPLETELY RESORBED AS PHYSICIAN REMOVED REMNANTS OF THE BIOENVELOPE AND ANTIBIOTIC DISC. THE PHYSICIAN STATES THAT THE REPORTED SEROMA IS RELATED TO THE ELUPRO BIOENVELOPE AND NOT PROCEDURE RELATED. NO FURTHER DETAILS ARE AVAILABLE REGARDING THE REPORTED EVENT, SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Seroma

  MAUDE report 25610885 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL WAS RECEIVED FROM AN ELUTIA SALES REPRESENTATIVE REGARDING A PATIENT ADVERSE EVENT. IT WAS REPORTED THAT, THE PATIENT HAD A POCKET REVISION WITH A CRTD BIV PACEMAKER IMPLANT ON (B)(6) 2025 ALONG WITH THE IMPLANT OF A MEDIUM ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL - CMCV-124-MED, LOT NUMBER - UNKNOWN). THE SALES REPRESENTATIVE NOTED THAT THE PATIENT HAD AN INFECTION ON (B)(6) 2025. THE DEVICE WAS REMOVED ON (B)(6) 2025 AND A NEW DEVICE WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PHYSICIAN CONFIRMED THAT THE ELUPRO DEVICE WAS NOT THE CAUSE OF THE INFECTION. NO FURTHER INFORMATION REGARDING THIS EVENT IWAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 22911269 ↗