RENASYS EDGERecalls & reported problems across all models
Smith & Nephew Medical Limited · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one RENASYS EDGE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 3
We found 3 models of RENASYS EDGE by Smith & Nephew Medical Limited in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, 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).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
RENASYS EDGE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- Mar 11, 2024Open, Classified
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Z-1597-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Mar 11, 2024Open, Classified
Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
Z-1596-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported RENASYS EDGE problems
Device problems
- Suction Failure12
- Failure of Device to Self-Test11
- Adverse Event Without Identified Device or Use Problem3
- Defective Alarm3
- Suction Problem2
- Arcing1
- Charging Problem1
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Wound Infection2
- Abscess1
- Cellulitis1
- Drug Resistant Bacterial Infection1
- Impaired Healing1
- Necrosis1
- Post Operative Wound Infection1
RENASYS EDGE models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RENASYS EDGE 66803126Negative Pressure Wound Therapy Powered Suction Pump1 recall28 reports
- RENASYS EDGE 66803139Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
- RENASYS EDGE 66803140Negative Pressure Wound Therapy Powered Suction Pump1 recall0 reports
Recent RENASYS EDGE adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Smith & Nephew Medical Limited products
All Smith & Nephew Medical Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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