RENASYS EDGE 66803126Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 05000223498634), received between Mar 28, 2024 and Nov 3, 2025 — classified as 4 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K223041); 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.

Recalls naming this device

1. Oct 2, 2024Open, Classified

   Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

   Z-0516-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2025Failure to Charge; Failure to Power Up; Charging Problem; Failure to Charge; Failure to Power Up; Charging Problem

  IT WAS REPORTED THAT, THE RENASYS EDGE PUMP WAS NOT CHARGING. PATIENT USED THE DEVICE FOR ONE MONTH FOR HIS RIGHT FOOT, FOLLOWING A THIRD TOE AMPUTATION. AT SOME POINT THE WOUND DEHISCED AND TREATMENT STOPPED FOR A PERIOD OF TWO WEEKS. RE-ESTABLISHMENT OF THERAPY WAS COMMENCED ON (B)(6) 2025, BUT THE DEVICE WOULD NOT POWER ON. THE DEVICE WAS CHARGED THE NIGHT BEFORE, IN ANTICIPATION OF THERAPY BEING RESTARTED. DIFFERENT OUTLETS WERE USED THROUGHOUT THE CHARGING PERIOD BUT STILL THE DEVICE WOULD NOT TURN ON. UPON HOLDING THE FAR-LEFT BUTTON BELOW THE SCREEN FOR 10 SECONDS OR GREATER, THERE WERE NO SUCCESSFUL RESULTS. IT IS UNKNOWN HOW THE TREATMENT WAS CONTINUED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 23459716 ↗
• InjuryJul 31, 2025Obstruction of Flow; Failure of Device to Self-Test; Inadequate User Interface; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Failure of Device to Self-Test; Inadequate User Interface; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING NPWT, TWO (2) RENASYS EDGE PUMPS FAILED USER INTERFACE DURING SELF TEST PERFORMED BY NURSE, ONE (1) RENASYS EDGE PUMP KEPT THROWING BLOCK ISSUES. ADDITIONALLY, DURING THE TIME OF THERAPY PATIENT WAS ADMITTED TO THE HOSPITAL FOR INFECTION OF THE WOUND. PATIENT BELIEVES IT IS A RESULT OF THE WOUND VACUUM NOT WORKING. IT IS UNKNOWN WHICH SPECIFIC PUMP WAS ASSOCIATED WITH EACH ISSUE (USER INTERFACE FAILURE, BLOCK ISSUES AND INFECTION). IT IS UNKNOWN HOW THE TREATMENT WAS RESUMED AND THERE WAS A DELAY GREATER THAN TWO HOURS FOR EACH INCIDENT. IT IS UNKNOWN HOW THE INFECTION WAS TREATED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Wound Infection

  MAUDE report 22675410 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING NPWT WITH A RENASYS EDGE PUMP, ON (B)(6) 2024 THE PATIENT AND WOUND CARE NURSE NOTED DISCOLORATION & WARMTH TO SURGICAL SITE. ON (B)(6) 2024 THE RENASYS EDGE PUMP WAS REMOVED AS THE ARE WAS ERYTHEMIC AND TENDER WITH DARK BROWN, FOUL-SMELLING DISCHARGE, AS WELL AS PAIN. THE PATIENT WAS DIAGNOSED WITH SURGICAL SITE INFECTION AND ABDOMINAL WALL CELLULITIS. CULTURES INDICATE THE GROWING OF E COLI, MRSA, AND STREPTOCOCCUS AGALACTIAE FOR WHICH IV ANTIBIOTICS WERE INITIATED. THIS WAS TREATED ON (B)(6) 2024 WITH AN INCISION AND DRAINAGE OF PURULENT ABDOMINAL WALL ABSCESS WITH WOUND DEBRIDEMENT/SHARP EXCISION OF EXTENSIVE NECROTIC TISSUE AND WASHOUT PERFORMED. ON (B)(6) 2024 AN ABDOMINAL PHOTO SCAN APPEARS TO SHOW A FRESHLY CLEANSED WOUND WITH RED GRANULATION WITHIN THE WOUND BED AND PINK EDGES. ON (B)(6) 2024 THE PATIENT SOUGHT ADDITIONAL WOUND CONSULT DUE TO DELAYED WOUND HEALING AND AN EXCISIONAL SKIN/SUBCUTANEOUS TISSUE DEBRIDEMENT WITH LOCAL/TOPICAL ANESTHETIC WAS PERFORMED ON THE OPEN SURGICAL WOUND LOCATED ON THE ABDOMEN ¿ MIDLINE WITH LARGE AMOUNT OF SEROSANGUINOUS DRAINAGE NOTED ALONG WITH NECROTIC TISSUE AND ADHERENT SLOUGH. ALSO, SILVER NITRATE WAS US

  Patient problems: Cellulitis; Drug Resistant Bacterial Infection; Impaired Healing; Necrosis; Post Operative Wound Infection; Purulent Discharge; Wound Infection

  MAUDE report 22025218 ↗
• MalfunctionFeb 18, 2025Arcing; Arcing

  IT WAS REPORTED THAT, DURING NPWT WITH ONE (1) RENASYS EDGE, IT WAS NOTICED THAT THE CORD WAS WORN, FRAYED AND HAD BEGUN SPARKING DUE TO WEAR AND TEAR. IT IS UNKNOWN HOW THE TREATMENT WAS CONTINUED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21404734 ↗
• MalfunctionOct 1, 2024Defective Alarm; Failure of Device to Self-Test; Defective Alarm; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE RENASYS EDGE PUMP FAILED THE LEAK TEST. THE CONTEXT IN WHICH THIS OBSERVATION WAS MADE IS UNSPECIFIED, FOR WHICH PATIENT INVOLVEMENT IS PENDING TO BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20348894 ↗
• MalfunctionSep 30, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT, DURING SELF-TEST ONE (1) RENASYS EDGE PUMP FAILED THE OVER VACUUM CUT-OFF TEST. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340117 ↗
• MalfunctionSep 30, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT, DURING SELF-TEST ONE (1) RENASYS EDGE PUMP FAILED THE FLOW TEST AND THE OVER VACUUM CUT-OFF TEST. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338666 ↗
• MalfunctionSep 30, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE RENASYS EDGE PUMP FAILED THE LEAK AND OVER VACUUM SELF- TEST. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338030 ↗
• MalfunctionSep 25, 2024Defective Alarm; Contamination; Failure of Device to Self-Test; Device Contamination with Chemical or Other Material; Defective Alarm; Contamination; Failure of Device to Self-Test; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT, ONE (1) RENASYS EDGE PUMP FAILED BOTH: THE LEAK TEST AND OVER VACUUM CUT-OFF, IN ADDITION THE PUMP IS CONTAMINATED WITH CARBON. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306387 ↗
• MalfunctionSep 25, 2024Defective Alarm; Failure of Device to Self-Test; Defective Alarm; Failure of Device to Self-Test

  IT WAS REPORTED THAT THE RENASYS EDGE PUMP FAILED THE LEAK TEST. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306108 ↗
• MalfunctionSep 25, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT, A RENASYS EDGE PUMP FAILED THE SELF-TEST. AS THIS HAPPENED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305983 ↗
• MalfunctionSep 25, 2024Suction Problem; Suction Problem

  IT WAS REPORTED THAT, A RENASYS EDGE PUMP FAILED THE FLOW TEST, LEAK TEST AND OVER VACUUM TEST, AND NEEDS REPLACEMENT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305889 ↗
• MalfunctionSep 25, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT, ONE (1) RENASYS EDGE PUMP FAILED SET TEST (FLOW TEST- OVER VACUUM CUT-OFF). AS THIS HAPPENED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305760 ↗
• MalfunctionSep 25, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT, A RENASYS EDGE PUMP FAILED SELF TEST. AS THIS HAPPENED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305728 ↗
• MalfunctionSep 25, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT, DURING TREATMENT, THE RENASYS EDGE PUMP WAS WORKING FINE FOR A FEW DAYS. PATIENT WAS RECEIVING A DRESSING AND WHEN THEY RESTARTED THERAPY, THE PUMP SUCKED DOWN BUT SAID CRITICAL AIR LEAK. WHEN A SELF TEST WAS PERFORMED, IT FAILED THE LEAK TEST AND VACUUM CUT OFF TESTS. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT PUMP. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305623 ↗
• MalfunctionJul 24, 2024Failure of Device to Self-Test; Failure of Device to Self-Test

  IT WAS REPORTED THAT A RENASYS EDGE PUMP FAILED SELF-TEST. NO CASE REPORTED; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822363 ↗
• MalfunctionJul 24, 2024Failure of Device to Self-Test; Suction Failure; Failure of Device to Self-Test; Suction Failure

  IT WAS REPORTED THAT ONE (1) RENASYS EDGE PUMP FAILED ITS SELF-TEST, LEAK TEST, AND VACUUM CUTOFF. SINCE THIS WAS NOTICED DURING INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19822314 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A NPWT WITH A RENASYS EDGE PUMP PLACED ON THE PATIENT'S LEFT AXILLA, THE CARE TEAM AT THE WOUND CLINIC DISCOVERED AN ABSCESS IN THE PATIENT'S RIGHT RIB AREA DURING AN APPOINTMENT ON (B)(6) 2024. THE NPWT WAS DISCONTINUED, AND THE PATIENT WAS ADVISED TO SEEK FURTHER CARE FOR THE ABSCESS AT THE HOSPITAL. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 AND DISCHARGED ON (B)(6) 2024. THE NPWT HAS NOT BEEN RESUMED; HOWEVER, THE PATIENT HAS AN APPOINTMENT AT WOUND CLINIC SCHEDULED FOR (B)(6) 2024. FURTHER INFORMATION IS UNAVAILABLE.

  Patient problems: Abscess

  MAUDE report 19653717 ↗
• MalfunctionApr 5, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT, A RENASYS EDGE PUMP CRITICAL LEAK WARNINGS, DRESSING AND CANISTER WERE CHANGED AND DRESSING HAD A GOOD SEAL BUT DID NOT GET A SUCTION, AFTER A TROUBLESHOOTING THE DEVICE STILL SHOWED THE ALARM. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055335 ↗
• MalfunctionApr 5, 2024Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  IT WAS REPORTED THAT A RENASYS EDGE PUMP FAILED SELF TEST - LEAK AND OVER VACUUM CUT OFF, WAS VERY LOUD AND WILL NOT GET A SEAL. NO CASE INVOLVED; THEREFORE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055021 ↗
• MalfunctionMar 28, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING NPWT, ONE (1) RENASYS EDGE PUMP IS NOT SUPPLYING THERAPY AS IT APPEARS THAT IT IS JUST RUNNING AND NOT PROGRESSING TO THE 125 MMHG THERAPY STATUS. THE DRESSING AS FLAT NOT RAISIN-LIKE IN APPEARANCE. THE ADHESIVE HAS SMOOTHED DOWN, REPLACED THE CANISTER, ADDED ADDITIONAL TAPE BUT NOTHING SEEMS HELP. IT WAS NOTED A FAILURE ON SOME OF THE SYSTEM CHECK INDICATORS. NO INJURY TO PATIENT WAS REPORTED. THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997576 ↗
• MalfunctionMar 28, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING A NPWT, WHEN THE RENASYS EDGE PUMP WAS RE-START TO THE THERAPY AFTER THE DRESSING CHANGE, THE DRESSING WASN'T DRAWING DOWN AND GETTING A SEAL. THE DEVICE FAILED THE SELF-TEST, THE LEAK TEST AND THE FLOW TEST. WE SWAPPED OUT THE DEVICE WITH A DIFFERENT ONE AND IT GAINED A SEAL JUST FINE AFTER THAT. THE TREATMENT WAS RESUMED, USING A S+N BACK-UP DEVICE. THERAPY WAS DELAYED FOR JUST OVER 60 MINUTES. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997562 ↗
• MalfunctionMar 28, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT, ONE RENASYS EDGE PUMP FAILED SELF TEST. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18997467 ↗
• MalfunctionMar 28, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT, ONE RENASYS EDGE PUMP FAILED SELF TEST. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18995571 ↗
• MalfunctionMar 28, 2024Suction Failure; Suction Failure

  IT WAS REPORTED THAT ONE (1) RENASYS EDGE PUMP FAILED THE FLOW TEST:, THE LEAK TEST AND THE OVER VACUUM CUT-OFF. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18994805 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K223041. One submission often covers many models, so check the product and lot details in each record.

• Z-1596-2024 · Mar 11, 2024 · Open, Classified
  RENASYS EDGE 300ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing. Product Number: 66803139
• Z-1597-2024 · Mar 11, 2024 · Open, Classified
  RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140