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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00859389005348), received between Jan 17, 2025 and Jun 24, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Degraded” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 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 AN 84 YR. OLD MALE PATIENT WAS IMPLANTED WITH AN ABBOTT BIVENTRICULAR ICD GENERATOR (CHANGE-OUT) ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-LRG; LOT#: M26C1083). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A SEROMA AND UPON PHYSICIAN EVALUATION OF THE POCKET, THE DEVICE WAS EXPLANTED ON (B)(6) 2026. CULTURES TAKEN DURING THE EXPLANT PROCEDURE WERE NEGATIVE FOR BACTERIA PRESENCE. 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 25610884 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  NOTIFICATION WAS RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT AN 86 YR. OLD FEMALE PATIENT WAS IMPLANTED WITH A MEDTRONIC BI-VENTRICULAR PACEMAKER GENERATOR ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-LRG; LOT #M26C1092). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A SEROMA (SPECIFIC DATE IS UNKNOWN). THE IMPLANTED SYSTEM (CIED AND ELUPRO DEVICES) REMAIN IN PLACE AND THE PATIENT MONITORED. 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 25610883 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  NOTIFICATION WAS RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT A 37 YR. OLD MALE PATIENT WAS IMPLANTED WITH AN BOSTON SCIENTIFIC EMBLEM S-ICD ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-LRG; LOT #M26C1092). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A SEROMA (SPECIFIC DATE IS UNKNOWN) AND THAT THE DEVICE(S) REMAIN IN PLACE. 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 25610882 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  NOTIFICATION WAS RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT A 74 YR. OLD MALE PATIENT WAS IMPLANTED WITH AN ABBOTT DUAL CHAMBER CIED ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-LRG; LOT #M26C1092). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A HEMATOMA (SPECIFIC DATE IS UNKNOWN). PATIENT WAS BEING FOLLOWED AND THE SYSTEM (CIED AND ELUPRO DEVICES) REMAINED IN PLACE. THE PHYSICIAN STATES THAT THE REPORTED HEMATOMA 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: Hematoma

  MAUDE report 25610873 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  NOTIFICATION WAS RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT A 55 YR. OLD MALE PATIENT WAS IMPLANTED WITH A MEDTRONIC BIVENTRICULAR CRT-D GENERATOR ON (B)(6) 2026 USING AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (CMCV-124-LRG; LOT #M26D1100). IT WAS REPORTED THAT THE PATIENT HAD DEVELOPED A SMALL SEROMA - SPECIFIC DATE AND SPECIFIC COURSE OF TREATMENT IS UNKNOWN. THE PHYSICIAN STATES THAT THE REPORTED SEROMA IS RELATED TO THE ELUPRO BIOENVELOPE AND NOT PROCEDURE RELATED. THE ELUPRO DEVICE REMAINS IMPLANTED AND 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 25610872 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA THE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE REGISTRY POST MARKET CLINICAL STUDY THAT A 71 YR. OLD MALE PATIENT (SUBJ. (B)(6) UNDERWENT A BATTERY/GENERATOR CHANGE-OUT PROCEDURE ON (B)(6) 2025 USING AN ELUPRO BIOENVELOPE (MODEL # CMCV-124-LRG; LOT #M25B1030). A COMBINATION OF SALINE AND IRRISEPT WERE UTILIZED TO REHYDRATE THE ELUPRO DEVICE FOR 5 SECONDS. NO CONCERNS OR COMPLAINTS WERE REPORTED DURING OR AFTER THE IMPLANTATION WAS COMPLETE. ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT OF POSSIBLE CELLULITIS, WITH NO POCKET INFECTION OBSERVED. THE PATIENT WAS PRESCRIBED 100MG DOXYCYCLINE. THE ADVERSE EVENT WAS SUSPECTED TO BE POSSIBLY RELATED TO BOTH THE CIED PROCEDURE AND THE ELUPRO BIOENVELOPE DEVICE. AT SUBSEQUENT PATIENT FOLLOW-UP, THE REPORTED CELLULITIS HAD RESOLVED WITHOUT SEQUELAE, NO FURTHER INFORMATION IS AVAILABLE REGARDING THIS EVENT, SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Cellulitis

  MAUDE report 24824269 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  A 75-YEAR-OLD MALE PATIENT WAS IMPLANTED WITH AN ELUPRO DEVICE (CMCV-124-LRG, LARGE, M25G1163) ON (B)(6) 2025 WITH A BIOTRONIK ACTICOR 7 VR-T DX ICD BY THE IMPLANTING PHYSICIAN. THIS PATIENT IS SUBJECT (B)(6) ENROLLED IN THE POST-MARKET CLINICAL STUDY, ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE REGISTRY STUDY. A COMBINATION OF SALINE AND IRRISEPT WERE UTILIZED TO REHYDRATE THE DEVICE FOR 35 SECONDS. USE OF IRRISEPT AS A HYDRATION SOLUTION WAS NOTED. NO CONCERNS OR COMPLAINTS WERE NOTED DURING OR AFTER THE COMPLETION OF THE IMPLANTATION PROCEDURE. ON (B)(6) 2025, THE PATIENT WAS REPORTED TO HAVE A POSSIBLE INFECTION WHICH WAS REPORTED AS PROBABLY RELATED TO THE PROCEDURE; AND A POSSIBLE ALLERGIC REACTION WHICH WAS NOTED AS POSSIBLY RELATED TO THE ELUPRO DEVICE. THE PATIENT WAS PRESCRIBED 100MG OF DOXYCYCLINE. THE INFECTION HAS NOT YET BEEN CONFIRMED, AND THE EVENT IN THE CLINICAL REPORT IS LISTED AS ONGOING.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Unspecified Immune System Problem

  MAUDE report 24780597 ↗
• InjuryAug 22, 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 BIVICD WITH AV NODE PACEMAKER IMPLANT ON (B)(6) 2026 ALONG WITH THE IMPLANT OF A LARGE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL CMCV-124-LRG, LOT M25C1060). AT DEVICE CHECK, THE SITE BECAME AWARE THAT THE PATIENT DEVELOPED RED OOZING AND WAS TREATED WITH ORAL ANTIBIOTICS. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH BROWN LIQUID OOZING; IV ANTIBIOTICS WERE GIVEN. ON (B)(6) 2025 THE DEVICE WAS EXPLANTED. ANOTHER DEVICE WAS RE-IMPLANTED ON (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 22878007 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL WAS RECEIVED FROM THE ELUTIA REPRESENTATIVE REGARDING A PATIENT IN AN ELUTIA REGISTRY STUDY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT HAD A POCKET REVISION WITH A PACEMAKER IMPLANT ALONG WITH THE IMPLANT OF A LARGE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL CMCV-124-LRG, LOT M25A1005). ON 06/10/2025, THE SITE BECAME AWARE (PATIENT ONSET (B)(6) 2025) THAT THE PATIENT DEVELOPED A HEMATOMA AND WAS TREATED WITH ORAL ANTIBIOTICS (DOXYCYCLINE) AND RIVAROXABAN (HELD 3 DAYS). AFTER (B)(6) 2025, THE PATIENT DID NOT NOTE ANY SYMPTOMS RELATED TO A HEMATOMA. THE SITE ALSO NOTED THAT THE PATIENT DID NOT HAVE ANY EXISTING CONDITIONS OR COMORBIDITIES WHICH COULD HAVE CONTRIBUTED TO THE HEMATOMA. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT BUT IF ELUTIA RECEIVES MORE INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Hematoma

  MAUDE report 22777214 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL WAS RECEIVED FROM THE ELUTIA REPRESENTATIVE REGARDING A PATIENT IN AN ELUTIA REGISTRY STUDY. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT HAD A POCKET REVISION WITH A PACEMAKER IMPLANT ALONG WITH THE IMPLANT OF A LARGE ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL: CMCV-124-LRG, LOT: M25B1030). ON 05/30/2025, SITE BECAME AWARE THAT THE PATIENT DEVELOPED A HEMATOMA AND WAS TREATED WITH ORAL ANTIBIOTICS (DOXYCYCLINE) AS WELL AS OXYCODONE. ON 06/10/2025 THE SITE NOTED THE HEMATOMA WAS NOT RESOLVED AND THE PATIENT WAS HOSPITALIZED. THE HEMATOMA WAS DRAINED AND THE PATIENT WAS TREATED AGAIN WITH ORAL ANTIBIOTICS (DOXYCYCLINE). NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT BUT IF ELUTIA RECEIVES MORE INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Hematoma

  MAUDE report 22777203 ↗
• InjuryFeb 19, 2025Degraded; Degraded

  SALES REPRESENTATIVE NOTIFIED BY PHYSICIAN THAT A FEMALE PATIENT PRESENTED WITH A DISLODGED LEAD FOR CARDIAC IMPLANTABLE DEVICE DATA/CHECK AND CAME IN FOR A LEAD REVISION ON (B)(6) 2024. ORIGINAL DEVICE USED WAS AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL # CMCV-124-LRG, LOT # M24L1303). THE ELUPRO BIOENVELOPE INCLUDING DISC AND POUCH SUTURE (ALL PART OF ELUPRO BIOENVELOPE) WAS GONE EXCEPT FOR TISSUE PAPER-LIKE REMNANTS. THE CARDIAC IMPLANTABLE DEVICE HAD DROPPED IN THE POCKET AND THE LEADS WERE NOT NEAT. THE PATIENT'S TISSUE WAS FRIABLE. VICRYL SUTURE WAS STILL IN THE POCKET. SURGICAL INTERVENTION WAS REQUIRED WHERE THE LEAD WAS RE-ATTACHED TO THE HEART AND A CANGAROO ENVELOPE DEVICE WAS USED TO RE-IMPLANT THE CARDIAC IMPLANTABLE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417436 ↗
• InjuryJan 17, 2025Degraded; Degraded

  SALES REPRESENTATIVE NOTIFIED BY PHYSICIAN THAT A 70 YEAR OLD PATIENT PRESENTED WITH CARDIAC LEAD DISLODGED FOR CARDIAC IMPLANTABLE DEVICE AT DEVICE CHECK AND CAME IN FOR A LEAD REVISION ON (B)(6) 2024 (TWO DAYS AFTER INITIAL IMPLANT). ORIGINAL ELUTIA DEVICE USED WAS AN ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE (MODEL # CMCV-124-LRG, LOT # M24L1303). THE PATIENT UNDERWENT LEAD REVISION PROCEDURE TWO DAYS AFTER INITIAL IMPLANT. ELUPRO RIFAMPIN/MINOCYCLINE DISK WAS PRESENT. FRAGMENTS OF ELUPRO EXTRACELLULAR MATRIX ECM POUCH AS WELL AS THE SUTURE WERE STILL IN THE POCKET. CARDIAC IMPLANTABLE DEVICE HAD DROPPED AND LEADS WERE DISORGANIZED. LEAD(S) WERE RE-ATTACHED TO THE HEART AND A CANGAROO ENVELOPE DEVICE WAS USED TO RE-IMPLANT THE CARDIAC IMPLANTABLE DEVICE. PHYSICIAN DESCRIBES THE ELUPRO DEVICE AS POSSIBLY RELATED TO THE INCIDENT/EVENT OF RAPID BREAKDOWN OF ELUPRO (ECM) ALLOWING THE CARDIAC IMPLANTABLE DEVICE AND LEADS TO MOVE FROM INITIAL PLACEMENT BEFORE POCKET (ELUPRO DEVICE) COULD MATURE. THE PHYSICIAN ALSO MENTIONS THE PATIENT'S TISSUE WAS FRIABLE AND COULD ALSO HAVE CONTRIBUTED TO THE INCIDENT/EVENT. THE PHYSICIAN DESCRIBES THE PATIENT AS DOING WELL FOLLOWING TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21181040 ↗