ACTIV.A.C. ™ iOn PROGRESS™ RTMGSM01/USRecalls & reported problems

Summary

The FDA's MAUDE database contains 472 adverse event reports that list this exact device (DI 00849554005617), received between Mar 8, 2018 and Jul 27, 2026 — classified as 11 deaths, 353 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Collapse” (80 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 472 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Alarm System; Suction Failure

  On 29-Jun-2026, the following information was received by the patient: The patient reported the ACTIV.A.C.¿ Therapy System with iOn Progress¿ Remote Therapy Monitoring alarmed "Canister Full" when the canister was not full and stopped therapy without alarming. The graft allegedly failed due to the malfunction.On 13-Jul-2026, the following information was received via fax by the physician: The physician indicated the reported graft failure was caused or contributed to by the ACTIV.A.C.¿ Therapy System with iOn Progress¿ Remote Therapy Monitoring. A lack of suction from the ACTIV.A.C.¿ Therapy System with iOn Progress¿ Remote Therapy Monitoring resulted in the skin graft not adhering properly to the underlying wound bed, contributing to the graft failure. The ACTIV.A.C.¿ Therapy System with iOn Progress¿ Remote Therapy Monitoring malfunctioned by failing to maintain adequate suction throughout the entire battery life of the unit. The provider confirmed that the V.A.C.® Dressing type in use at the time of the alleged event was the V.A.C.® GRANUFOAM¿ Dressing; however, the V.A.C.® Dressing lot number was unknown. The patient will require an additional procedure to place another skin gr

  Patient problems: Graft failure

  MAUDE report 50045964 ↗
• InjuryMar 3, 2026Insufficient Device Problem Information

  ON 30-MAR-2026, A DEVICE EVALUATION OF THE ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON 30-DEC-2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2026, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2026, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND THE DEVICE PASSED AND MET SPECIFICATIONS AFTER PATIENT PLACEMENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Bacterial Infection

  MAUDE report 24501553 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A DEVICE EVALUATION OF THE ACTIV.A.C.¿ THERAPY SYSTEM WITH ION PROGRESS¿ REMOTE THERAPY MONITORING WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON (B)(6) 2026, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2026, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2026, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND THE DEVICE PASSED AND MET SPECIFICATIONS AFTER PATIENT PLACEMENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24400459 ↗
• InjuryNov 6, 2025Suction Problem; Suction Problem

  ON (B)(6) 2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2025, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM QUALITY ENGINEERING, AND NO FAILURES WERE FOUND WITH THE DEVICE RELATED TO THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 23485324 ↗
• InjuryOct 23, 2025Decrease in Suction; Decrease in Suction

  ON 02-OCT-2025, THE FOLLOWING INFORMATION RECEIVED VIA CLINICAL RECORDS FROM THE NURSE PRACTITIONER WERE REVIEWED: ON (B)(6) 2025, THE PATIENT PRESENTED WITH A YEAST RASH AROUND THE WOUND ALLEGEDLY FROM THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. NYSTATIN-TRIAMCINOLONE OINTMENT WAS PRESCRIBED FOR SEVEN DAYS. ON 16-OCT-2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE NURSE: THE YEAST INFECTION DEVELOPED AS A RESULT OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM FAILING TO MAINTAIN ADEQUATE SUCTION, WHICH CAUSED WOUND DRAINAGE TO ACCUMULATE BENEATH THE V.A.C.® DRESSING. ON 26-AUG-2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2025, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND THE DEVICE PASSED AND MET SPECIFICATIONS AFTER PATIENT PLACEMENT. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Fungal Infection

  MAUDE report 23375239 ↗
• InjuryJul 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS ALLEGEDLY NOT MAINTAINING AN ADEQUATE SEAL DUE TO SURROUNDING SCAR TISSUE. AS A RESULT, NECROTIC TISSUE DEVELOPED AT THE WOUND SITE. THE NURSE PRACTITIONER IS PLANNING TO DEBRIDE THE WOUND. ON (B)(6) 2025, THE FOLLOWING INFORMATION RECEIVED VIA CLINICAL RECORDS FROM THE NURSE PRACTITIONER WERE REVIEWED: THE VISIT NOTED DATED (B)(6) 2025 INDICATED THE WOUND BED WAS COVERED WITH FIBRIN. THE PATIENT STATED THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS LEFT IN PLACE FOR LONGER THAN 2 HOURS WITHOUT PROPER FUNCTION BEFORE THE DRESSING WAS REPLACED. MARGINS ARE ROLLED. V.A.C.® THERAPY WAS HELD WITH POSSIBILITY OF DISCONTINUING AT NEXT CLINIC VISIT. MECHANICAL DEBRIDEMENT WAS COMPLETED. PATIENT WILL BENEFIT FROM EXCISIONAL DEBRIDEMENT OF WOUND EDGES WITH FIBROTIC TISSUE AND SCARRING TO ALLOW FOR PROPER HEALING. REFERRAL PLACED TO PLASTIC RECONSTRUCTIVE SURGERY TO EVALUATE FOR SURGERY. ON 20-AUG-2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED THE QUALITY CONTROL CHECKS AND M

  Patient problems: Impaired Healing

  MAUDE report 22543170 ↗
• DeathMar 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 15-APR-2025, A DEVICE EVALUATION WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON 30-DEC-2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE SOLVENTUM SERVICE CENTER, AND THE DEVICE PASSED AND MET SPECIFICATION PRIOR TO PATIENT PLACEMENT. ON (B)(6) 2025, THE DEVICE WAS PLACED WITH THE PATIENT. ON 15-APR-2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM QUALITY ENGINEERING AND NO FAILURES WERE FOUND WITH THE DEVICE RELATED TO THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21531703 ↗
• InjuryFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: THE PATIENT STATED HIS LEG WAS AMPUTATED DUE TO NOT HAVING PROPER CARE. ON 31-MAR-2025, A DEVICE EVALUATION WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON (B)(6) 2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2024, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2025, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Impaired Healing; Ischemia

  MAUDE report 21406548 ↗
• InjuryAug 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: ON (B)(6) 2024, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS ALLEGEDLY NOT WORKING PROPERLY AND SHE WAS INSTRUCTED TO REMOVE THE V.A.C.® DRESSING. THE PATIENT REMOVED THE V.A.C.® THERAPY DRESSING AND HAD A LARGE AMOUNT OF BLOODY DRAINAGE AND PRESENTED TO THE EMERGENCY ROOM. THE WOUND WAS ALLEGEDLY SURGICALLY CLOSED, AND SHE WAS DISCHARGED ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED. ON 09-AUG-2024, A DEVICE EVALUATION WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON 17-JUN-2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2024, THE DEVICE WAS PLACED WITH THE PATIENT. ON 06-AUG-2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955820 ↗
• InjuryJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22-MAY-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: ON 20-MAY-2024, V.A.C.® THERAPY WAS PLACED ON HOLD DUE TO AN ALLEGED YEAST INFECTION AROUND THE WOUND SITE; NYSTATIN POWDER WAS PRESCRIBED FOR A FEW DAYS AND V.A.C.® THERAPY IS SCHEDULED TO RESUME TODAY. ON 03-JUN-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE HOME HEALTH AGENCY: ON 20-MAY-2024, THE HOME HEALTH NURSE NOTED A PERIWOUND YEAST INFECTION THAT WAS BEING TREATED WITH NYSTATIN POWDER. ON 23-MAY-2024, SUBSEQUENT HOME NURSE VISIT OCCURRED AND THERE WAS NO MENTION OF PERIWOUND YEAST INFECTION AT THIS TIME. V.A.C.® THERAPY WAS REAPPLIED. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS PENDING RETURN OF THE DEVICE.

  Patient problems: Fungal Infection

  MAUDE report 19519836 ↗
• InjuryMay 22, 2024No Audible Alarm; Alarm Not Visible; Premature Discharge of Battery; No Audible Alarm; Alarm Not Visible; Premature Discharge of Battery

  ON 18-JUL-2024, A DEVICE EVALUATION WAS COMPLETED BY SOLVENTUM QUALITY ENGINEERING. ON 19-JUL-2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A SOLVENTUM SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON 20-JUL-2023, THE DEVICE WAS PLACED WITH THE PATIENT. ON 18-JUL-2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY SOLVENTUM QUALITY ENGINEERING AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Bacterial Infection

  MAUDE report 19378225 ↗
• InjuryMay 20, 2024Suction Problem; Suction Problem

  ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT: SHE ALLEGEDLY DEVELOPED SOME IRRITATION AROUND THE WOUND. HER HOME HEALTH NURSE USED THE DERMATAC¿ DRAPE THAT WAS ORDERED BY THE WOUND CARE CENTER, WHICH MADE HER SKIN WORSE. SHE STATED THAT SHE WOULD BE FOLLOWING UP WITH HER DOCTOR TOMORROW TO ASSESS THE WOUND. SHE ADDED THAT SHE WOULD POSSIBLY BE ADMITTED TO THE HOSPITAL BECAUSE THE WOUND HAD WORSENED. ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE DOCTOR OF OSTEOPATHIC MEDICINE: THE PATIENT'S SKIN IRRITATION WAS ASSESSED TO BE MODERATE TO SEVERE, WHICH WAS CONFIRMED TO CAUSE THE WOUND TO DETERIORATE. THE PROVIDER CONFIRMED THE ALLEGED EVENT TO BE A COMBINATION OF THE DERMATAC¿ DRAPE NOT SEALING PROPERLY, AND THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM NOT FUNCTIONING PROPERLY. THE PATIENT REQUIRED SURGICAL DEBRIDEMENT AT THE WOUND CARE CENTER. WOUND CARE TREATMENT WAS CHANGED, V.A.C.® THERAPY WAS DISCONTINUED, AND THE PATIENT IS IMPROVING. ADDITIONAL INFORMATION FROM THE PROVIDER WAS REQUESTED VIA FAX REGARDING THE INFORMATION RECEIVED. ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE DOCTOR OF OSTEOPATHIC MEDICI

  Patient problems: Impaired Healing; Skin Inflammation/ Irritation

  MAUDE report 19355294 ↗
• InjuryMay 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 08-APR-2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2024, THE NURSE WAS CONCERNED ABOUT THE APPEARANCE OF THE WOUND DURING A DRESSING CHANGE AND PROVIDED PICTURES TO THE PHYSICIAN. THE WOUND ALLEGEDLY LOOKED MOIST AND RED. THE PATIENT WAS THEN SEEN IN THE PHYSICIAN'S OFFICE WHERE THE WOUND WAS CLEANSED AND A CULTURE WAS PERFORMED. ON (B)(6) 2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE WOUND ALLEGEDLY APPEARED RED AND SWOLLEN SO THE PATIENT WENT TO PHYSICIAN'S OFFICE. ON 22-APR-2024, THE FOLLOWING INFORMATION WAS PROVIDED BY THE PHYSICIAN: AN INFECTION WAS CONFIRMED. V.A.C.® THERAPY MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. IT IS UNKNOWN IF V.A.C.® THERAPY WAS APPLIED PROPERLY. V.A.C.® THERAPY WAS DISCONTINUED AND ANTIBIOTICS WERE PRESCRIBED. A DEVICE HISTORY RECORD REVIEW OF V.A.C.® SIMPLACE¿ DRESSING LOT NUMBER A05276V008 IS PENDING COMPLETION. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS PENDING COMPLETION.

  Patient problems: Bacterial Infection

  MAUDE report 19238267 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11-DEC-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2023, THE PATIENT HAD A MISSED HOME HEALTH VISIT, AND THE V.A.C.® DRESSING DID NOT GET CHANGED. ON (B)(6) 2023, THE HOME HEALTH NURSE CAME OUT TO PERFORM A DRESSING CHANGE AND ADVISED THE PATIENT TO GO TO THE EMERGENCY ROOM DUE TO THE APPEARANCE OF THE WOUND. THE PATIENT WAS PRESCRIBED ORAL ANTIBIOTICS FOR A WOUND INFECTION. ON 27-DEC-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: WHEN NURSE WENT OUT TO PERFORM A DRESSING CHANGE ON (B)(6) 2023, THE WOUND SHOWED SIGNS AND SYMPTOMS OF INFECTION, SO THE PATIENT WAS ADVISED TO GO TO THE EMERGENCY ROOM. THE PATIENT WAS GIVEN ANTIBIOTICS AND V.A.C.® THERAPY RESUMED SUNDAY, (B)(6) 2023. THE NURSE COULD NOT SAY IF V.A.C.® THERAPY CAUSED OR CONTRIBUTED TO THE INFECTION; THERE WERE NO TECHNICAL ISSUES REPORTED AND V.A.C.® THERAPY REMAINED ON WITH DRESSING INTACT UNTIL THE NURSE REMOVED ON (B)(6) 2023. WOUND CARE ORDERS WERE TO CHANGE DRESSING ONCE PER WEEK DUE TO GRAFT PLACEMENT IN ORDER TO ALLOW GRAFT INCORPORATION. ON 03-JAN-2024, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: ON (B)(6) 2023, THE PATIENT STARTED CARE WITH

  Patient problems: Bacterial Infection

  MAUDE report 18487973 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 28-FEB-2024, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2023, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2024, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY A KCI SERVICE CENTER AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18356298 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 31-MAR-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR POSSIBLE INFECTION. THE PATIENT RESUMED V.A.C.® THERAPY ON (B)(6) 2023; HOWEVER, RESULTS INDICATED THE PATIENT HAD METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) AND WAS READMITTED TO THE HOSPITAL ON (B)(6) 2023. ON 04-APR-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE PATIENT DID NOT RESUME V.A.C.® THERAPY ON (B)(6) 2023 BECAUSE HE WAS STILL BEING TREATED FOR MRSA. THE PATIENT IS A QUADRIPLEGIC AND DIDN'T HAVE AN INFECTION PRIOR TO STARTING V.A.C.® THERAPY. DRESSINGS WERE CHANGED APPROPRIATELY; THEREFORE, THE CAUSE OF THE INFECTION COULD NOT BE DETERMINED. ON 23-JAN-2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2023, THE DEVICE WAS PLACED WITH THE PATIENT. ON 19-APR-2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTIO

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 16825146 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2023, THE PATIENT WAS IN THE HOSPITAL ALLEGEDLY DUE TO THE INCISION OPENING. V.A.C.® THERAPY WOULD RESUME AFTER POTENTIAL DISCHARGE ON (B)(6) 2023. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2023, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2023, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Wound Dehiscence

  MAUDE report 16679326 ↗
• InjuryMar 9, 2023Suction Problem; Suction Problem

  ON 13-FEB-2023, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS PLACED ON HOLD DUE TO PENDING RESULTS OF A WOUND CULTURE AND WOUND ALLEGEDLY NOT PROGRESSING AS WELL AS DOCTOR HAD ANTICIPATED.

  Patient problems: Bacterial Infection

  MAUDE report 16510407 ↗
• InjuryFeb 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE NURSE: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM THAT WAS TREATING MULTIPLE WOUNDS LOCATED ON THE PATIENT'S BACK WAS REMOVED DUE TO AN ALLEGED INFECTION. ON (B)(6) 2023, THE FOLLOWING INFORMATION RECEIVED VIA CLINICAL RECORDS FROM THE PHYSICIAN WERE REVIEWED: WOUND CULTURES GREW PROTEUS AND PSEUDOMONAS, BOTH SENSITIVE TO CIPROFLOXACIN. BASED ON THE STRONG FRUIT ODOR IT IS SUSPECTED THE PSEUDOMONAS BECAME RESISTANT TO CIPROFLOXACIN AND IS ALLEGEDLY FLOURISHING UNDER V.A.C.® THERAPY. THE PATIENT WAS PRESCRIBED AN ORAL ANTIBIOTIC ON (B)(6) 2023 AND WOUND CARE WAS CHANGED TO PACKING DAILY. ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: V.A.C.® THERAPY WAS DISCONTINUED DUE TO INFECTION OF THE WOUNDS. THE AMOUNT OF DRAINAGE AND THE MOIST ENVIRONMENT OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM ALLEGEDLY CAUSED THE INFECTION TO FLOURISH. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS FUNCTIONING PROPERLY. WOUND CARE WAS CHANGED TO AN ALTERNATIVE DRESSING, AND THE PATIENT'S WOUNDS ARE IMPROVING. ON (B)(6) 2023 A DEVICE EVALUATION WA

  Patient problems: Bacterial Infection

  MAUDE report 16455559 ↗
• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 24-JAN-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: ON (B)(6) 2023, THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED ALLEGEDLY FOR SURGERY TO OPEN UP THE WOUND DUE TO AN ALLEGED UNDERMINING ISSUE. THE PATIENT REMAINS HOSPITALIZED AND V.A.C.® THERAPY MAY RESUME. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2022, THE DEVICE WAS PLACED WITH THE PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.

  Patient problems: Tissue Breakdown

  MAUDE report 16422033 ↗
• InjuryFeb 21, 2023No Audible Alarm; Alarm Not Visible; Suction Problem; No Audible Alarm; Alarm Not Visible; Suction Problem

  ON 23-JAN-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM ALLEGEDLY MALFUNCTIONED, DID NOT ALARM, AND THE PATIENT'S SKIN GRAFT FAILED. THE PHYSICIAN INDICATED THE DEVICE KEPT THE WOUND TOO WET. ON 09-FEB-2023, THE FOLLOWING INFORMATION RECEIVED VIA CLINICAL RECORDS FROM PHYSICIAN WERE REVIEWED: ON 17-JAN-2023, PATIENT UNDERWENT SKIN GRAFTING. THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED (B)(6) 2023. APPEARED THE GRAFT PARTIALLY TOOK. THE WOUND BED APPEARED TOO MOIST AND THERE IS QUESTION AS TO IF THE ACTIV.A.C.¿ THERAPY SYSTEM WAS WORKING PROPERLY. THE WOUND BED IS CLEAN WITHOUT SIGNS OF INFECTION. NEW ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM DELIVERED TO PATIENT HOME TO BE RESTARTED AT WOUND CLINIC. WILL FOLLOW UP TO DISCUSS REPEAT SKIN GRAFTING. ON 10-FEB-2023, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE NURSE: V.A.C.® THERAPY WAS RESTARTED (B)(6) 2023. PATIENT'S WOUND IS IMPROVING. ON 20-FEB-2023 A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON 08-DEC-2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE

  Patient problems: Failure of Implant

  MAUDE report 16408474 ↗
• InjuryFeb 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON (B)(6) 2023, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE HOME HEALTH NURSE: THE PATIENT ALLEGEDLY DEVELOPED AN INFECTION AFTER REMOVING AND APPLYING V.A.C.® THERAPY HIMSELF. ON (B)(6) 2022, A MODERATE AMOUNT OF PURULENT DRAINAGE WAS NOTED DURING HIS VISIT. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2023, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2022, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Unspecified Infection

  MAUDE report 16287292 ↗
• InjuryJan 26, 2023Unexpected Shutdown; Unexpected Shutdown

  ON 09-FEB-2023, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE DEVICE PASSED AND MET SPECIFICATIONS. ON (B)(6) 2022, THE DEVICE WAS PLACED WITH THE PATIENT. ON 09-FEB-2023, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER AND THE DEVICE PASSED AND MET SPECIFICATIONS. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

  Patient problems: Osteomyelitis

  MAUDE report 16246873 ↗
• MalfunctionDec 16, 2022Smoking; Smoking

  ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM POWER CORD ALLEGEDLY STARTED SPARKING/SMOKING WHEN THE CORD WAS PLUGGED INTO THE UNIT. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THERE WAS NO HARM OR INJURY TO THE PATIENT OR BYSTANDERS AS A RESULT OF THE ALLEGED EVENT. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT: THE ALLEGED SMOKE WAS CONTINUOUS AND OCCURRED AT THE POWER SUPPLY. THE SMOKE CEASED ONCE SHE UNPLUGGED THE CORD FROM THE OUTLET. ON 14-NOV-2022, THE DEVICE AND POWER CORDS WERE TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER, AND PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2022, THE DEVICE AND POWER CORDS WERE PLACED WITH THE PATIENT. ON 22-NOV-2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY THE KCI SERVICE CENTER AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. THE AFFECTED POWER CORDS WERE NOT AVAILABLE TO RETURN TO KCI QUALITY ENGINEERING FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15996212 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 22-NOV-2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE PATIENT: THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM WAS REMOVED ALLEGEDLY DUE TO BLEEDING FROM HIS WOUND. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE HOME HEALTH NURSE: UPON ARRIVING AT THE PATIENT'S HOME, THERE WAS A POOL OF BLOOD UNDERNEATH THE PATIENT'S FOOT. THE NURSE DESCRIBED THE ALLEGED BLEEDING EVENT AS SHOOTING OUT OF THE WOUND. THE NURSE STATED THE PATIENT WAS ADMITTED TO THE HOSPITAL AND RECEIVED A BLOOD TRANSFUSION. THE NURSE BELIEVED THE BLEEDING EVENT WAS DUE TO THE PROCEDURE DONE ON (B)(6) 2022, BUT WAS NOT CERTAIN. ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS PROVIDED TO KCI BY THE TRIAGE NURSE: THE NURSE CONFIRMED THE PATIENT WAS HOSPITALIZED FOR BLEEDING AND RECEIVED A BLOOD TRANSFUSION. NO ADDITIONAL INFORMATION WAS PROVIDED. ON (B)(6) 2022, A DEVICE EVALUATION WAS COMPLETED BY KCI QUALITY ENGINEERING. ON (B)(6) 2022, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2022, THE DEVICE WAS PLACED WITH THE PATIENT. ON (B)(6) 2022, THE DEVICE WAS TES

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15996101 ↗

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.