CanGaroo EnvelopeRecalls & reported problems across all models

We found 4 models of CanGaroo Envelope by Elutia Med LLC in the FDA's device registry (GUDID). Together they are named in 114 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2016 and Sep 26, 2026 — classified as 111 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported CanGaroo Envelope problems

CanGaroo Envelope models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• CanGaroo Envelope CMCV-009-XLG

  Mesh, Surgical
  43 reports
• CanGaroo Envelope CMCV-009-MED

  Mesh, Surgical
  34 reports
• CanGaroo Envelope CMCV-009-LRG

  Mesh, Surgical
  32 reports
• CanGaroo Envelope CMCV-009-XXL

  Mesh, Surgical
  5 reports

Recent CanGaroo Envelope adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50907236 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50903010 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bioenvelope was part of a system revision due to infection. There were no additional adverse patient effects reported. The bioenvelope was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50872732 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that this bio-envelope was part of a system revision due to infection. There was no additional adverse patient effects reported. The bio-envelope was explanted.

  Patient problems: Unspecified Infection

  MAUDE report 50785875 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM ELUTIA SALES REPRESENTATIVE REPORTING "EROSION OF DEVICE." MALE PATIENT HAD NEW BIV PACER IMPLANTED (B)(6) 2023 USING THE CANGAROO ENVELOPE (MODEL # CMCV-009-LRG, LOT # M21G1274). BOTH BIV PACER AND CANGAROO ENVELOPE WERE EXPLANTED (B)(6) 2023 DUE TO EROSION OF THE DEVICE. PHYSICIAN REPORTED THE POSSIBLE CAUSE OF THE EVENT AS "[FELLOW] HAS ONLY IMPLANTED A CANGAROO ONCE, USED IT FOR AN ELDERLY PATIENT THAT HAD THIN SKIN, NOT SURE WHAT TO THINK, MAYBE THE FELLOW'S TECHNIQUE CLOSING THE POCKET COULD HAVE SOMETHING TO DO WITH IT." HE FURTHER STATED THAT BECAUSE THIS WAS THE FIRST TIME HE HAD HAD A CANGAROO PLACED IN A PATIENT, AND THE FELLOW HAD NOT PREVIOUSLY USED ONE OR BEEN TRAINED ON ITS IMPLANTATION, HE COULD NOT SPEAK TO REMODELING, MIGRATION, OR EROSION WITH THE USE OF THIS DEVICE. EVENT RELATIONSHIP TO BOTH PROCEDURE AND AZIYO DEVICE REPORTED AS "POSSIBLY RELATED." PATIENT RECEIVED MEDICATION IN ADDITION TO EXPLANT, IS REPORTED AS DOING WELL, AND IS SCHEDULED TO HAVE PACEMAKER IMPLANT ON CONTRALATERAL SIDE.

  Patient problems: Pocket Erosion

  MAUDE report 18344337 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL FROM SALES REP WITH ADVERSE EVENT REPORT AS FOLLOWS: POCKET INFECTION. PATIENT HAD NEW BIV PACEMAKER PLACED ON (B)(6) 2023 WITH CANGAROO DEVICE (MODEL # CMCV-009-MED, LOT #M23G1206). ON (B)(6) 2023, PATIENT WAS SEEN IN OFFICE AND NOTED TO HAVE A POCKET HEMATOMA. FLUID FROM HEMATOMA WAS DRAINED AND CULTURED, WITH RESULTS POSITIVE FOR ENTEROCOCCUS AND E. COLI. PATIENT STARTED ON ANTIBIOTICS AND SENT HOME. DOCTOR REPORTED ON (B)(6) 2023 THAT PATIENT'S WOUND WAS GETTING WORSE AND HE PLANNED HOSPITAL ADMISSION FOLLOWING UPCOMING OFFICE VISIT. EVENT REPORTED AS "POSSIBLY RELATED" TO CANGAROO ENVELOPE AS WELL AS THE PROCEDURE TO IMPLANT IT. PHYSICIAN STATED CAUSE MAY BE RELATED TO SURGICAL TECHNIQUE AS HE HAD A SECOND PATIENT (WITHOUT CANGAROO DEVICE) WHO DEVELOPED INFECTION WITH THE SAME BACTERIA.

  Patient problems: Unspecified Infection

  MAUDE report 18143126 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL RECEIVED FROM SALES REP WITH ADVERSE EVENT REPORT AS FOLLOWS: POCKET INFECTION. 65-YEAR OLD MALE HAD SUBQ ICD (BOSTON SCIENTIFIC) DEVICE PLACED (B)(6) 2023 USING THE CANGAROO ENVELOPE (CMCV-009-XXL, LOT #M23F1182). PATIENT BECAME FEBRILE WITHIN 24 HOURS AND WAS PLACED ON TWO ANTIBIOTICS POST-OPERATIVELY. ICD AND CANGAROO EXPLANTED (B)(6) 2023 FOR POCKET INFECTION, WITH APPROXIMATELY 500CC OF PUS REMOVED. CULTURES WERE PERFORMED AND RESULTS WERE NEGATIVE. PATIENT RECEIVED A WOUND VAC FOR THE SITE OF THE EXPLANT AND PLAN IS TO SEND PATIENT HOME EVENTUALLY WITH A LIFE VEST. EXPLANTING PHYSICIAN STATED THAT INFECTION WAS "DEFINITELY RELATED" TO THE ICD DEVICE BUT COULD NOT RULE OUT INVOLVEMENT OF THE CANGAROO ENVELOPE.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 18143012 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL RECEIVED FROM AZIYO SALES REP REPORTING EXPLANT DUE TO INFECTION. PATIENT DESCRIBED AS 50-YEAR OLD MALE WITH DE NOVO S-ICD IMPLANT IN (B)(6) 2022 WITH EXPLANT ONE WEEK LATER DUE TO PUS NOTED. REPORTED AS "POSSIBLY RELATED" TO PROCEDURE AND "POSSIBLY RELATED" TO AZIYO DEVICE. PATIENT RECEIVED MEDICATION AND WEARING A LIFE VEST, AWAITING ANOTHER IMPLANT. DATES IN THIS REPORT ARE APPROXIMATE--ACTUAL DATES UNKNOWN.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 14858264 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A CIED (CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE) AND AN AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-XLG, LOT NUMBER M20N1423579) IMPLANTED ON (B)(6) 2021, PRESENTED WITH POCKET INFECTION AND WOUND DEHISCENCE. DEHISCENCE FIRST NOTED ON (B)(6) 2022 AND DEVICE EVENTUALLY PROTRUDED THOUGH THE SKIN. THE AZIYO DEVICE WAS EXPLANTED WITH THE REMOVAL OF THE CIED ON (B)(6) 2022.

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 13932745 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL WAS RECEIVED FROM THE AZIYO CLINICAL RESEARCH MANAGER REGARDING A PATIENT IN AN (B)(6) STUDY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A DE NOVO PACEMAKER IMPLANT WITH THE IMPLANT OF AN AZIYO CANGAROO ENVELOPE (MODEL CMCV-009-MED, LOT M21H1305). ON (B)(6) 2021, SITE BECAME AWARE THAT THE PATIENT DEVELOPED AN INFECTION IN THE POCKET AND WAS TREATED WITH ORAL ANTIBIOTICS (MINOCYCLINE FOR 10 DAYS) AND EVENT RESOLVED WITHOUT SEQUELAE BY (B)(6) 2021. PHYSICIAN NOTED THAT PATIENT PULLED ON INTERNAL SUTURE, POTENTIALLY OPENING THE POCKET. NO FURTHER DETAILS ARE AVAILABLE REGARDING THIS EVENT BUT IF AZIYO RECEIVES MORE INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Bacterial Infection

  MAUDE report 13497431 ↗
• MalfunctionFeb 4, 2022Material Disintegration

  CANGANROO POUCH DISINTEGRATED ON ATTEMPTED INSERTION INTO AICD (AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR) POCKET. AFTER ABX (ANTIBIOTIC) SOAK. REMOVED INTACT. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13450681 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL RESEARCH MANAGER OF CANGAROO STUDY REPORTED PATIENT ADVERSE EVENT AS FOLLOWS: ON (B)(6) 2021, PATIENT RECEIVED DE NOVO IMPLANT OF A BIVENTRICULAR PACEMAKER AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BIV AICD) WITH CANGAROO ENVELOPE (MODEL CMCV-009-LRG, LOT NUMBER M21E1177636). ON FOLLOW-UP VISIT (B)(6) 2022, PATIENT HAD SIGNS OF INFECTION AT IMPLANT SITE AND WAS ADMITTED TO THE HOSPITAL. DEVICE EXPLANTED ON (B)(6) 2022 AND PATIENT STARTED ON CEPHALEXIN. PHYSICIAN REPORTED THAT PATIENT HAD A WOUND DEHISCENCE WHICH RESULTED IN POCKET INFECTION. PHYSICIAN REPORTED THAT EVENT WAS "PROBABLY RELATED" TO THE IMPLANT PROCEDURE. PATIENT IS MALE, (B)(6).

  Patient problems: Hematoma; Unspecified Infection; Wound Dehiscence

  MAUDE report 13443917 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTIFIED BY EMAIL FROM AZIYO SALES REP REGARDING A PATIENT WHO RECEIVED AN ICD GENERATOR CHANGE WITH IMPLANT OF CANGAROO ENVELOPE (MODEL CMCV-009-XXL, LOT M21F1209) ON (B)(6) 2021. SEROMA NOTED (B)(6) 2021. DEVICE EXPLANTED (B)(6) 2022. CULTURES RETURNED POSITIVE FOR PROPIONIBACTERIUM ACNE.

  Patient problems: Bacterial Infection; Seroma

  MAUDE report 13393076 ↗
• InjuryJan 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL RECEIVED FROM PHYSICIAN DESCRIBING THE FOLLOWING EVENT: PATIENT UNDERWENT A LEAD REVISION PROCEDURE FROM A PRIOR ICD PLACEMENT ON (B)(6) 2021 UTILIZING AN AZIYO CANGAROO ENVELOPE (CMCV-009-LRG, LOT #M21C1109). ON (B)(6) 2021, PATIENT REPORTED POCKET PAIN AND SWELLING WHICH WAS OBSERVED AT PHYSICIAN'S OFFICE. ON (B)(6) 2021, PATIENT WAS REEVALUATED AND SENT FOR SEROMA EXTRACTION, AT WHICH TIME A PURULENT WHITE MATERIAL WITHOUT ODOR WAS EXTRACTED FROM THE POCKET. BLOOD CULTURES AND WOUND CULTURES WERE NEGATIVE. ICD AND LEADS REMOVED. PATIENT HOSPITALIZED AND INFECTIOUS DISEASE SERVICE CONSULTED. PATIENT PLACED ON IV ANTIBIOTICS AND CLEARED FOR RE-IMPLANT ON (B)(6) 2021.

  Patient problems: Seroma

  MAUDE report 13294315 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EMAIL RECEIVED FROM AZIYO REPRESENTATIVE WITH REPORT OF PATIENT WITH POST-OP POCKET INFECTION. CHANGE-OUT PROCEDURE OF AN ICD WITH AZIYO CANGAROO ENVELOPE DEVICE MODEL CMCV-009-XLG, LOT NUMBER M21D1130 WAS DONE ON (B)(6)2021. THE PATIENT RETURNED TO THE HOSPITAL TWO HOURS POST DISCHARGE AFTER HIS CHANGE-OUT PROCEDURE REPORTING A HEMATOMA. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2021 WITH SUSPECTED POCKET INFECTION AND WAS PLACED ON IV ANTIBIOTICS. THE ICD AND ACCOMPANYING CANGAROO ENVELOPE WERE EXPLANTED ON (B)(6) 2021. THE PHYSICIAN REPORTED THAT HE BELIEVES THAT THE HEMATOMA LED TO THE POCKET INFECTION AND WAS PROBABLY DUE TO THE PROCEDURE AND NOT CAUSED BY THE AZIYO DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 13170360 ↗

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