ACTIV.A.C.™ M8275058/5 M8275058/10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00849554001992), received between Apr 19, 2019 and Apr 19, 2019 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K063692); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 01-FEB-2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2019, THE DEVICE WAS PLACED WITH THE PATIENT. ON 17-APR-2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI QUALITY ENGINEERING. A REVIEW OF THE DEVICE EVENT LOGS FOUND THE DEVICE WAS ABLE TO ADMINISTER V.A.C.® THERAPY FOR THE TIME PERIOD OF THERAPY. A DEVICE HISTORY REVIEW FOR LOT NUMBER 5884886V007 DETERMINED THAT THE LOT NUMBER WAS NOT A VALID V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER.

  Patient problems: Necrosis

  MAUDE report 8530971 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063692. One submission often covers many models, so check the product and lot details in each record.

• Z-0665-2010 · Nov 4, 2009 · Terminated
  AC Power Cords, 110V Manufactured by Electri-Cord Manufacturing Company in Westfield, PA. Power Cord #340225 used with Activac Model 340000, and ActiVAC (Canadian) Model 340013.