CanGaroo Envelope CMCV-009-XXLRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00859389005119), received between Mar 3, 2020 and Nov 15, 2023 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE WAS PART OF A SYSTEM REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9808668 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT REIMPLANT WAS DONE FOR THE PATIENT'S DEVICE. PATIENT HAD HEMATOMA. DEVICE WAS PLACED SUBMUSCULAR VERSUS PREVIOUSLY INTRAMUSCULAR POSITION.

  Patient problems: Hematoma

  MAUDE report 9781251 ↗