V.A.C.® GRANUFOAM™ M8275051/5 M8275051/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00849554002104), received between Jun 11, 2021 and May 14, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2025Material Fragmentation; Material Fragmentation

  ON 24-APR-2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: A PATIENT ALLEGEDLY HAD SMALL BITS OF BLACK FOAM EMBEDDED IN THE WOUND. THIS MAKES A TOTAL OF THREE PATIENTS NOW; SOME WITH AS MANY AS 75 PIECES OF BLACK FOAM. THERE WAS SOME MATERIAL PRESENT COMING FROM THE SMALL V.A.C.® GRANUFOAM¿ DRESSING OUT OF THE PACKAGE. ON 29-APR-2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: THE MOST RECENT PATIENT HAD V.A.C.® GRANUFOAM¿ DRESSING PLACED, LOT NUMBER C12078V011. THE PREVIOUS TWO PATIENTS WERE TRANSFERRED FROM ANOTHER ACUTE CARE FACILITY WITH EMBEDDED V.A.C.® GRANUFOAM¿ DRESSING SO THERE ARE NO LOT NUMBERS AVAILABLE. ALL THREE PATIENTS REQUIRED SHARP AND MECHANICAL DEBRIDEMENT TO REMOVE THE EMBEDDED FOAM. THE EXACT DATES OF OCCURRENCE OF THE TWO PREVIOUS PATIENTS WERE UNKNOWN. ON 30-APR-2025, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER C12078V011. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE ALLEGED PATIENT WITH EMBEDDED SMALL V.A.C.® GRANUFOAM¿ DRESSING FOR LOT NUMBER C12078V011 IS REPORTED UNDER MDR-3009897021-2025-00018. THE ALLEGED PREVIOUS TWO PATIENTS WITH EMBEDDED V.A.C.® GRANUFOAM¿ DR

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 22022622 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE PATIENT HAS A DOCTOR'S APPOINTMENT TOMORROW DUE TO THE HOME HEALTH NURSE REPORTING AN ALLEGED ODOR FROM THE WOUND ON (B)(6) 2022. ON 08-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM REMAINS IN USE, HOWEVER, THE PHYSICIAN PRESCRIBED DOXYCYCLINE AND FLUCONAZOLE TO TREAT SKIN IRRITATION AND A YEAST INFECTION ALLEGEDLY FROM THE V.A.C.® DRAPE. ON 28-JUN-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PHYSICIAN ASSISTANT: ON 03-JUN-2022, THE PHYSICIAN ORDERED AN ORAL ANTIFUNGAL MEDICATION TO TREAT A PERIWOUND FUNGAL INFECTION AND DUE TO CONCERN FOR PERIWOUND CELLULITIS, AN ORAL ANTIBIOTIC WAS ALSO PRESCRIBED. A WOUND CULTURE WAS NOT OBTAINED. ON 21-JUN-2022, A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 60331235V010 AND ASSOCIATED V.A.C.® DRAPE WAS COMPLETED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Cellulitis; Fungal Infection

  MAUDE report 14936911 ↗
• InjuryMar 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 07-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2022, AFTER REMOVAL OF THE V.A.C.® GRANUFOAM¿DRESSING BY A FAMILY MEMBER, THE PATIENT ALLEGEDLY STARTED BLEEDING AND PRESENTED TO THE HOSPITAL FOR MEDICAL ATTENTION. THE PATIENT REPORTED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS RESUMED. ON 10-MAR-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY (B)(6): ON (B)(6) 2022, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINT OF BLEEDING FROM HIS SURGICAL SITE. THE PHYSICIAN NOTED MINOR BLEEDING TO A SMALL SUBCUTANEOUS VESSEL AND USED A SUTURE TO LIGATE. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS RESUMED. ON (B)(6) 2022, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 9353894V011 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS. THE V.A.C.® GRANUFOAM¿ DRESSING WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13971396 ↗
• InjuryJun 11, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 12-MAY-2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE HOME HEALTH AGENCY AND WOUND CARE CENTER NURSES WERE INCORRECTLY APPLYING THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM BY PLACING THE V.A.C.® GRANUFOAM¿ DRESSING ON THE PATIENT'S SKIN WHICH ALLEGEDLY CAUSED WORSENING OF THE WOUND AND AN INCREASE IN THE WOUND SIZE. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS SUBSEQUENTLY DISCONTINUED AND THE PATIENT WILL REPORTEDLY CONSULT WITH THE PLASTIC SURGEON. NO ADDITIONAL INFORMATION WAS PROVIDED. RECORDS REVIEW NOTED THE FOLLOWING: ON (B)(6) 2021 AND (B)(6) 2021, THE PATIENT'S WOUND WAS OBSERVED AND EXHIBITED AN INCREASE IN THE LENGTH FROM 5.00CM TO 5.40CM AND DEPTH FROM 0.20CM TO 0.50CM. THE WOUND'S WIDTH REMAINED THE SAME AT 3.00CM. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON (B)(6) 2021 AND WAS DISCONTINUED ON (B)(6) 2021. ON 17-MAY-2021, A DEVICE HISTORY RECORD REVIEW OF THE V.A.C.® GRANUFOAM¿ DRESSING WAS PERFORMED. ALL END RELEASE TESTING OF PRODUCT AND PACKAGING MET SPECIFICATIONS.

  Patient problems: Tissue Breakdown

  MAUDE report 11987236 ↗