CanGaroo Envelope CMCV-009-XLGRecalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00859389005072), received between Sep 19, 2016 and Sep 25, 2026 — classified as 42 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (1 report).

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 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50903010 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A S-ICD (PACEMAKER) IMPLANTED ON (B)(6) 2021 AND AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-XLG, LOT NUMBER M20D1136513) PRESENTED WITH POCKET INFECTION. THE AZIYO DEVICE WAS EXPLANTED AS PART OF THE REMOVAL OF THE ENTIRE S-ICD SYSTEM ON (B)(6) 2021. PATIENT HAD A HISTORY OF PREVIOUS INFECTION WITH ANOTHER IMPLANTATION OF A TRANSVENOUS DEVICE IN 2020. DUE TO ONGOING COMPLICATIONS, PATIENT REQUESTED ENTIRE SYSTEM BE REMOVED WITH NO PLANS FOR REPLACEMENT. THERE WAS NO ALLEGATION OF CANGAROO ENVELOPE CONTRIBUTING TO POSSIBLE INFECTION GIVEN PATIENT'S HISTORY OF INFECTIONS WITH PREVIOUS DEVICES.

  Patient problems: Bacterial Infection

  MAUDE report 12770842 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, AZIYO WAS NOTIFIED BY BUSINESS PARTNER BOSTON SCIENTIFIC THAT A PATIENT WITH A PULSE GENERATOR IMPLANTED ON (B)(6) 2021 AND AZIYO BIOLOGICS CANGAROO ENVELOPE (MODEL CMCV-009-XLG, LOT NUMBER M21D1130) PRESENTED WITH BACTEREMIA. THE AZIYO DEVICE WAS EXPLANTED AS PART OF THE REMOVAL OF THE ENTIRE CARDIOVASCULAR IMPLANTABLE ELECTRONIC DEVICE (CIED) SYSTEM ON (B)(6) 2021. THE PATIENT RECEIVED IV ANTIBIOTICS BEFORE AND AFTER THE EXPLANT AND THE POCKET WAS FLUSHED WITH VANCOMYCIN PRIOR TO BEING SUTURED CLOSED. PATIENT WAS REPORTEDLY DISCHARGED HOME WITH A WOUND VAC AND IS CURRENTLY DOING WELL. THE PHYSICIAN STATED THAT HE DID NOT BELIEVE THE AZIYO PRODUCT WAS RELATED TO, OR RESPONSIBLE FOR, THE INFECTION.

  Patient problems: Sepsis

  MAUDE report 12631298 ↗
• InjurySep 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021 A PATIENT HAD AN ICD CHANGE OUT PROCEDURE WHICH INCLUDED AN AZIYO BIOLOGICS CANGAROO ENVELOPE MODEL CMCV-009-XLG LOT NUMBER M21D1130. ON (B)(6) 2021 THE PATIENT HAD A POCKET REVISION PROCEDURE PERFORMED DUE TO REDNESS AND SWELLING AT THE SITE OF THE POCKET REVISION. REMNANTS OF THE AZIYO CANGAROO ENVELOPE WERE REMOVED AT THAT TIME.

  Patient problems: Inflammation

  MAUDE report 12543720 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD ORIGINAL ICD PLACEMENT IN 2016 WITH ICD CHANGE-OUT PROCEDURE ON (B)(6) 2021. SHE REPORTEDLY WENT SWIMMING POST-SURGERY AND DEVELOPED SOME PAIN, SWELLING AND REDNESS AT THE SITE. ANTIBIOTICS WERE PRESCRIBED BUT SHE DELAYED TAKING THEM FOR A WEEK. WHEN SHE PRESENTED TO THE PHYSICIAN, THE ICD SITE HAD AN OPEN WOUND WITH THE DEVICE EXPOSED, NO REDNESS, SOME SWELLING, AND YELLOW DRAINAGE. NO FEVER, CHILLS OR BODY ACHES. DEVICE WAS EXPLANTED ALONG WITH AZIYO ENVELOPE. POCKET WAS IRRIGATED AND NEW ICD AND AZIYO ENVELOPE IMPLANTED. PATIENT WAS DISCHARGED HOME ON ORAL ANTIBIOTICS. CUTURES TAKEN AT THE TIME OF EXPLANT SHOWED "NO GROWTH" SIX DAYS LATER.

  Patient problems: Unspecified Infection

  MAUDE report 12520449 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 01MAR2021 BY AZIYO SALES REPRESENTATIVE THAT THE PATIENT'S ICD GENERATOR WAS CHANGED OUT ON (B)(6) 2021 USING A CANGAROO ENVELOPE (MODEL #: CMCV-009-XLG; LOT #: M20K1262) HAVING BEEN SOAKED IN SALINE FOR 1 - 2 MINUTES. ON (B)(6) 2021, DOCTOR REPORTED THAT PATIENT HAD YELLOW PUS DRAINING FROM IMPLANT SITE. PATIENT WAS HOSPITALIZED FOR 3 DAYS FOR IV ANTIBIOTICS AND THEN DISCHARGED HOME ON ORAL ANTIBIOTICS FOR 7DAYS. INFECTION HAS NOW RESOLVED AND PATIENT IS IN GOOD HEALTH. PACEMAKER AND CANGAROO ENVELOPE REMAIN IMPLANTED. NO FURTHER DETAILS ARE AVAILABLE FOR THIS EVENT, SHOULD ADDITIONAL INFORMATION BE RECEIVED RELATED TO THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Unspecified Infection

  MAUDE report 11584749 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2021 BY AZIYO BUSINESS PARTNER BOSTON SCIENTIFIC THAT A CANGAROO ENVELOPE (MODEL CMCV-009-XLG, LOT# M20N1387) WAS USED IN AN ICD REPLACEMENT PROCEDURE ON (B)(6) 2021 FOR A (B)(6) YEAR-OLD MALE. ENVELOPE WAS PREPARED BY SOAKING IN ANCEF/GENTAMICIN/SALINE. PATIENT DEVELOPED HEMATOMA AND POCKET INFECTION AND WENT TO (B)(6) HOSPITAL WHERE THE ICD WAS EXPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT THE CANGAROO ENVELOPE WAS NOT REMOVED. PATIENT WAS TREATED WITH ANTIBIOTICS AND DOING WELL. NEW IMPLANT WAS PERFORMED TWO (2) DAYS LATER IN DIFFERENT SITE.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 11541480 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL CMCV-009-XLG; LOT #M20A1016) WAS USED WITH A BOSTON SCIENTIFIC CIED (MODEL # / SERIAL # UNKNOWN) AND IMPLANTED ON (B)(6) 2020. IT WAS REPORTED BY BSC THAT ON (B)(6) 2020 THE CIED DEVICE, LEADS, AND CANGAROO ENVELOPE WERE EXPLANTED DUE TO POCKET INFECTION WITH SEPSIS. THE DEVICE AND LEADS WILL NOT BE RETURNED FOR ANALYSIS. UNKNOWN IF ANTIBIOTICS WERE GIVEN. THIS ISSUE WAS REPORTED TO AZIYO BIOLOGICS BY BOSTON SCIENTIFIC ON (B)(6) 2020. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PHYSICIAN REGARDING SEPSIS DETERMINATION HAVE BEEN UNSUCCESSFUL UP TO TIME OF THIS REPORT. SHOULD AZIYO RECEIVE ANY ADDITIONAL INFORMATION REGARDING THIS EVENT, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 11098005 ↗
• InjuryDec 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL # CMCV-009-XLG, LOT# M20G1218) WAS IMPLANTED (DATE UNKNOWN) WITH A BOSTON SCIENTIFIC CRT-D (MODEL# / SERIAL # - UNKNOWN). THE PATIENT UNDERWENT A HEMATOMA EVACUATION PROCEDURE ON (B)(6) 2020 AND ULTIMATELY A DEVICE EXTRACTION ON (B)(6) 2020. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS FILING. SHOULD ANY ADDITIONAL DETAILS BE RECEIVED BY AZIYO, A SUPPLEMENTAL REPORT WILL BE FILED.

  Patient problems: Hematoma

  MAUDE report 10954218 ↗
• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AN AZIYO SALES REPRESENTATIVE ON 10/15/2020 THAT A MALE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH A BIV ICD (MODEL #: UNKNOWN, SERIAL #: UNKNOWN) USING A CANGAROO ENVELOPE (MODEL #: CMCV-009-XLG; LOT # M20A1038). PATIENT LATER RETURNED WITH PUS IN THE POCKET, REDNESS OF POCKET AND DIAGNOSED WITH A LOCAL POCKET INFECTION. THE PATIENT WAS TREATED WITH 5 DAYS OF ANTIBIOTICS AND THE BIV ICD DEVICE WAS EXPLANTED AND REPLACED WITH A SUBQ DEVICE. SALES REPRESENTATIVE LEARNED OF EVENT 2 - 3 WEEKS AFTER OCCURRENCE, DATES OF IMPLANT AND EXPLANT UNKNOWN. SHOULD ANY ADDITIONAL DETAILS BE RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: Unspecified Infection

  MAUDE report 10825182 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 09/24/2020 BY AZIYO BIOLOGICS CUSTOMER SERVICE, THAT CANGAROO ENVELOPE (MODEL #: CMCV-009-XLG; LOT #: M20A1040) WAS IMPLANTED WITH A BOSTON SCIENTIFIC CRTD (MODEL #: UNKNOWN; SERIAL #: UNKNOWN) ON (B)(6) 2020. THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION RESULTING IN DEVICE REMOVAL ON (B)(6) 2020. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED BY THE REPORTING FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 10736478 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER, BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL #: CMCV-009-XLG, LOT #: M20A1045) WAS USED WITH A BOSTON SCIENTIFIC DEVICE (MODEL # / SERIAL # - UNKNOWN) AND IMPLANTED ON (B)(6) 2020. ON (B)(6) 2020, THE SURGEON NEEDED TO REOPEN THE POCKET DUE TO A LEAD TIP BECOMING DISLODGED FROM THE HEART. A REPLACEMENT ECM ENVELOPE WAS USED AS THE PREVIOUS ENVELOPE WAS DAMAGED UPON DEVICE REMOVAL. NO MIGRATION WITHIN THE POCKET WAS NOTED AND IT WAS CONFIRMED THAT THE LEAD TIP HAD DISLODGED FROM THE HEART. THE ROOT CAUSE WAS LIKELY PATIENT INDUCED FROM EXCESSIVE ARM MOVEMENT.

  Patient problems: Insufficient Information; Twiddlers Syndrome

  MAUDE report 10477397 ↗
• InjuryAug 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO BIOLOGICS' BUSINESS PARTNER BOSTON SCIENTIFIC, THAT A CANGAROO ENVELOPE (MODEL # CMCV-009-XLG, LOT# M19F1231), IMPLANTED ON (B)(6) 2019, WAS PART OF A SYSTEM EXPLANT DUE TO INFECTION. EXPLANT DATE, EXPLANTING PHYSICIAN AND THE FACILITY WHERE THE EXPLANT PROCEDURE TOOK PLACE WERE NOT PROVIDED AS THERE WAS NO BOSTON SCIENTIFIC REPRESENTATIVE PRESENT DURING THE PROCEDURE. BOSTON SCIENTIFIC AWARENESS DATE WAS (B)(6) 2020. THE ISSUE WAS REPORTED TO AZIYO BIOLOGICS ON 7/30/2020.

  Patient problems: Unspecified Infection

  MAUDE report 10460795 ↗
• InjuryJul 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY AZIYO SALES REPRESENTATIVE ON (B)(6) 2020 THAT A PHYSICIAN REPORTED AN INFECTION FOLLOWING IMPLANT OF A BIV DEVICE USING A CANGAROO ENVELOPE (MODEL # CMCV-009-XLG, LOT# M20A1025) ON (B)(6) 2020. PHYSICIAN REPORTED GRAM NEGATIVE GROWING FROM POCKET AND LEAD TIP. PHYSICIAN STATED THAT "MOST LIKELY NOT INNOCULATION AT IMPLANT SITE SINCE THOSE ARE USUALLY GRAM POSITIVE. MOST LIKELY INNOCULATED AT HOME WATER IS NOTORIOUS FOR GIVING PSEUDOMONAS INFECTION A GRAM NEGATIVE." BIV DEVICE AND CANGAROO ENVELOPE WERE EXPLANTED ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 10261797 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WITH THE AZIYO CANGAROO PRODUCT HAD AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10016374 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AZIYO CANGAROO PRODUCT WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10015585 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AZIYO PRODUCT WAS EXPLANTED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10015555 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PULSE GENERATOR AND LEADS EXPLANTED DUE TO INFECTION/SEPSIS. AZIYO PRODUCT REMAINS IN SERVICE.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9781984 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO INFECTION AND EROSION WITH SEPSIS. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS PRODUCT WAS EXPLANTED. REPORT STATES AZIYO PRODUCT NOT RELATED TO EVENT.

  Patient problems: Pocket Erosion; Sepsis; Unspecified Infection

  MAUDE report 9781359 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RIGHT ATRIAL (RA) LEAD WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE RA LEAD WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9734522 ↗
• InjuryFeb 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRODUCT WAS PART OF A SYSTEM REVISION DUE TO INFECTION. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PRODUCT WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 9734519 ↗