V.A.C. FREEDOM™ 320000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00878237001516), received between Apr 6, 2018 and Sep 8, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (2 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS OF 12-AUG-2025, IT WAS REPORTED TO SOLVENTUM THAT A CIVIL RIGHTS ACTION HAD BEEN FILED IN THE UNITED STATES DISTRICT COURT DISTRICT OF (B)(6). IN THAT COMPLAINT PREPARED BY THE PLAINTIFF, THE FOLLOWING INFORMATION WAS REPORTED:¿ PATIENT HAD AN ENDARTERECTOMY ON (B)(6) 2022¿PATIENT RETURNED TO [TREATING FACILITY] ON (B)(6) 2022 DUE TO BLOOD CLOT/COMPARTMENT SYNDROME WITH ACUTE THROMBOTIC OCCLUSION OF THE RIGHT ILIAC STENT. ON (B)(6) 2022, THE PATIENT HAD TWO FASCIOTOMIES TO THE ANTERIOR RIGHT LOWER LEG, THEN REQUIRED AN ANTERIOR RIGHT LOWER LEG I&D LARGE HEMATOMA, JUST DISTAL AND BETWEEN THE TWO FASCIOTOMY SITES. PATIENT THEN HAD POSTOPERATIVE ANEMIA¿V.A.C. FREEDOM¿ THERAPY SYSTEM WAS FINALLY PROCURED, AND THE DECISION WAS MADE TO TRANSFER PATIENT TO [TREATING FACILITY] ON (B)(6) 2022¿IN PREPARATION FOR LEAVING [TREATING FACILITY], MEDICAL STAFF ATTACHED A V.A.C. FREEDOM¿ THERAPY SYSTEM TO THE PATIENT¿S RIGHT LEG¿ON (B)(6) 2022¿THE PATIENT WAS LETHARGIC DUE TO LOSS OF BLOOD FROM SURGICAL WOUNDS¿ON (B)(6) 2022, AT APPROXIMATELY 10:27AM, THE PATIENT HAD VERY, VERY LOW BLOOD PRESSURE, FEELING LIGHTHEADED, AND [THE PHYSICIAN] WAS NOTIFIED...ON (B)(6) 2022, AT APPROXIMATELY 10:43AM...

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22996209 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS OF (B)(6) 2025, IT WAS REPORTED TO (B)(4) THAT A CIVIL RIGHTS ACTION HAD BEEN FILED IN THE UNITED STATES DISTRICT COURT DISTRICT OF (B)(6). IN THAT COMPLAINT PREPARED BY THE PLAINTIFF, THE FOLLOWING INFORMATION WAS REPORTED: ¿UPON REMOVAL OF THE V.A.C.® GRANUFOAM¿ DRESSING, THE WOUND WAS NOTED TO HAVE A VERY STRONG FOUL ODOR AND THICK LAYER OF SLOUGH THROUGHOUT THE MIDDLE OF THE WOUND. THIS WAS NOTED BY THE RN ON (B)(6) 2022¿THE PATIENT STARTED ON ANTIBIOTICS¿ON (B)(6) 2022¿(B)(6)] DISCONTINUED THE V.A.C. FREEDOM¿ THERAPY SYSTEM. THE PATIENT STARTED THE V.A.C. FREEDOM¿ THERAPY SYSTEM AGAIN ON (B)(6) 2022¿ON (B)(6) 2022¿THE PATIENT¿S ROOM HAD A VERY STRONG ODOR. RIGHT INNER THIGH OF THE PATIENT WAS VERY, VERY, RED, WARM TO TOUCH, AND ¿VERY FIRM.¿ LPN CHECKED RIGHT GROIN AREA AND NOTICED SMELL COMING FROM GROIN AREA ¿WHERE V.A.C. FREEDOM¿ THERAPY SYSTEM ATTACHED.¿ THE PATIENT COMPLAINED OF LEG HURTING THROUGHOUT THE DAY¿ON (B)(6) 2022¿AGAIN AN ODOR FROM THE PATIENT¿S GROIN WOUND AND V.A.C. FREEDOM¿ THERAPY SYSTEM NOTED. RIGHT THIGH AREA STARTING TO WEEP, SKIN IS VERY TAUT...ON (B)(6) 2022, THE PATIENT HAD VERY, VERY LOW BLOOD PRESSURE¿PATIENT LEFT TO THE HOSPITAL BY AMBULANCE¿ON (

  Patient problems: Sepsis

  MAUDE report 22996071 ↗
• MalfunctionAug 6, 2021Thermal Decomposition of Device; Overheating of Device; Electrical Shorting; Thermal Decomposition of Device; Overheating of Device; Electrical Shorting

  ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE V.A.C. FREEDOM¿ THERAPY SYSTEM ALLEGEDLY WAS HOT TO THE TOUCH. THE NURSE CONFIRMED NO INJURY OCCURRED. ON (B)(6) 2021, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE THIRD-PARTY SERVICE PROVIDER: THE V.A.C. FREEDOM¿ THERAPY SYSTEM WAS SENT TO THE REPAIR TEAM DUE TO THE SYSTEM OVERHEATING. UPON INTERNAL EVALUATION, THE DEVICE EXHIBITED EVIDENCE OF THERMAL DAMAGE TO THE WIRES, PUMP, TUBING AND HOUSING. ON 12-MAY-2021, THE DEVICE WAS TESTED PER KCI QUALITY CONTROL PROCEDURE BY THE THIRD-PARTY SERVICE PROVIDER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON 27-MAY-2021, THE DEVICE WAS PLACED WITH THE PATIENT. ON 30-JUL-2021, KCI QUALITY ENGINEERING PERFORMED AN EVALUATION OF THE DEVICE. INTERNAL INSPECTION REVEALED CHARRING ON THE PUMP WIRING ASSEMBLY, PUMP AND TUBING. ADDITIONALLY, THERMAL DAMAGE WAS OBSERVED ON THE EXTERNAL HOUSING. ADDITIONAL INVESTIGATION OF THE DEVICE IS IN PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289215 ↗
• MalfunctionDec 5, 2020Temperature Problem; Misassembly During Maintenance/Repair; Temperature Problem; Misassembly During Maintenance/Repair

  ON 05-NOV-2020, KCI IDENTIFIED THE V.A.C. FREEDOM¿ THERAPY SYSTEM HAD THERMAL DAMAGE TO INTERNAL COMPONENTS. THERE WAS NO PATIENT INVOLVEMENT OR INJURY ASSOCIATED WITH THIS EVENT. KCI QUALITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THE UNIT'S HOUSING REVEALED BLACK RESIDUE BOTH INTERNAL AND EXTERNAL TO THE DEVICE. INTERNAL INSPECTION OF THE DEVICE REVEALED THERMAL DAMAGE ON THE COMPRESSOR CABLE. THE BATTERY WAS TESTED AND FUNCTIONED AS EXPECTED. FUNCTIONAL TESTING OF THE PUMP COULD NOT BE PERFORMED. ADDITIONAL INVESTIGATION OF THE DEVICE IS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10955506 ↗
• InjuryJun 11, 2020Overheating of Device; Improper or Incorrect Procedure or Method; Temperature Problem; Insufficient Device Problem Information; Overheating of Device; Improper or Incorrect Procedure or Method; Temperature Problem; Insufficient Device Problem Information

  ON (B)(6)2020, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S LEGAL REPRESENTATIVE: THE PATIENT REPORTEDLY SUSTAINED INJURIES AS A RESULT OF THE ALLEGED MISUSE OF THE V.A.C. FREEDOM¿ THERAPY SYSTEM AT THE PATIENT'S TREATING FACILITY ON OR ABOUT (B)(6)2019. THE PATIENT RETURNED TO THE TREATING FACILITY "FOR A DRESSING CHANGE AND AGAIN DUE TO A BURN TO THE BACK AS A RESULT OF THE ALLEGED MISUSE" OF THE V.A.C. FREEDOM¿ THERAPY SYSTEM BY THE TREATING FACILITY.

  Patient problems: Abrasion; Burn(s); Erythema; Injury; Skin Burning Sensation

  MAUDE report 10146159 ↗
• MalfunctionOct 24, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  ON 23-JUL-2019, THE FOLLOWING INFORMATION WAS REPORTED BY THE NURSE: THE V.A.C. FREEDOM¿ THERAPY SYSTEM ALLEGEDLY EXHIBITED A HOT ELECTRICAL SMELL. ON 31-JUL-2019, THE FOLLOWING INFORMATION WAS REPORTED BY THE NURSE: NO INJURY OR HARM OCCURRED TO PATIENT OR OTHERS. ON 11-JUN-2019, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE AND THE UNIT PASSED THE QUALITY CONTROL CHECKS. ON (B)(6) 2019, THE DEVICE WAS PLACED WITH THE PATIENT. ON 24-SEP-2019, KCI QUALITY ENGINEERING EVALUATED THE DEVICE AND DETERMINED THE UNIT'S BOTTOM HOUSING REVEALED BLACK RESIDUE BOTH INTERNAL AND EXTERNAL TO THE DEVICE. INTERNAL INSPECTION OF THE UNIT REVEALED DAMAGED INSULATION WHICH EXPOSED THE ELECTRICAL CONDUCTORS ON THE BATTERY CHARGER ASSEMBLY WIRING AND THE DATA PORT ASSEMBLY WIRING INDICATING THE SOURCE OF THE EVENT WAS AN ELECTRICAL SHORT IN THE UNIT'S BATTERY CHARGER ASSEMBLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9235134 ↗
• InjuryJan 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT ALLEGEDLY ACQUIRED AN INFECTION WHILE ON THE V.A.C. FREEDOM¿ THERAPY SYSTEM. NO ADDITIONAL INFORMATION IS AVAILABLE. A DEVICE EVALUATION OF (B)(4), AND A DEVICE HISTORY REVIEW OF LOT NUMBER 5453875V005 ARE CURRENTLY PENDING COMPLETION.

  Patient problems: Unspecified Infection

  MAUDE report 8289842 ↗
• InjuryNov 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2017, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE PATIENT ALLEGED HIS LEG HAD TO BE AMPUTATED DUE TO A FAULTY V.A.C. FREEDOM¿ NEGATIVE PRESSURE WOUND THERAPY SYSTEM. PER REVIEW OF THE PATIENT'S MEDICAL RECORDS: V.A.C. FREEDOM¿ THERAPY SYSTEM WAS APPLIED TO THE PATIENT'S RIGHT LOWER LEG. ON (B)(6) 2017, THE PATIENT PRESENTED TO THE HOSPITAL WITH A PAINFUL, COLD RIGHT FOOT. PATIENT WAS SWITCHED FROM COUMADIN TO ELIQUIS 1 MONTH PRIOR. PATIENT WAS PLACED ON HEPARIN BOLUS AND HEPARIN DRIP WITH A PREOPERATIVE DIAGNOSIS OF CRITICAL LIMB ISCHEMIA, RIGHT LEG WITH THROMBOSED RIGHT FEMORAL TO POSTERIOR TIBIAL ARTERY BYPASS GRAFT. THE PATIENT UNDERWENT A THROMBECTOMY OF A FEMORAL TO POSTERIOR TIBIAL ARTERY PROSTHETIC GRAFT WITH MEDIAL FASCIOTOMIES. V.A.C. FREEDOM¿ THERAPY WAS DISCONTINUED ON (B)(6) 2017 FOR A SURGICAL WOUND RELATED PROCEDURE NOTED AS RIGHT ABOVE THE KNEE AMPUTATION. ON 21-NOV-2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PHYSICIAN'S NURSE: THE PATIENT'S AMPUTATION WAS UNRELATED TO ACTIV.A.C.¿ THERAPY, AND WAS A RESULT OF THE PATIENT'S CHRONIC VASCULAR ISCHEMIA. ON 10-OCT-2017, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY K

  Patient problems: Tissue Breakdown

  MAUDE report 8096505 ↗
• InjuryApr 6, 2018No Pressure; No Pressure

  ON (B)(6) 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE PATIENT'S WOUND WAS MACERATED AND ALLEGEDLY THERE WAS EXUDATE POOLING AT THE WOUND SITE AND THE UNIT NOT ALARMING. ON APR 3 2018, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2018, THE PATIENT UNDERWENT DEBRIDEMENT TO REMOVE THE MACERATION. THE V.A.C. FREEDOM¿ SYSTEM WAS DISCONTINUED AT THAT TIME. THE PATIENT'S WOUND HAS BEEN IMPROVING SINCE. ON DEC 27 2017, THE DEVICE PASSED QUALITY CONTROL (QC) CHECKS AND MET SPECIFICATIONS BEFORE PLACEMENT WITH THE PATIENT. ON (B)(6) 2018, THE DEVICE WAS PLACED WITH THE PATIENT. ON MAR 13 2018, THE DEVICE WAS TESTED BY KCI QUALITY ENGINEERING PER QC PROCEDURES AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT. THE DEVICE PASSED THE PRESSURE ACCURACY CHECKS AND MAINTAINED PRESSURE AT 125 MMHG. ADDITIONALLY, THE UNIT PRODUCED ALARMS AS EXPECTED DURING STANDARD QC ALARM TESTING WITH NO UNEXPECTED ALARMS PRODUCED.

  Patient problems: Tissue Breakdown

  MAUDE report 7404419 ↗