RENASYS TOUCHRecalls & reported problems across all models
Smith & Nephew Medical Limited · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 126
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 4 models of RENASYS TOUCH by Smith & Nephew Medical Limited in the FDA's device registry (GUDID). Together they are named in 126 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2020 and Jan 27, 2022 — classified as 10 injuries, 116 malfunctions.
The most frequently reported specific device problem is “Failure to Charge” (43 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. 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
Most reported RENASYS TOUCH problems
Device problems
- Failure to Charge43
- False Alarm24
- Suction Failure24
- Defective Alarm12
- Obstruction of Flow9
- Protective Measures Problem7
- Defective Component6
- Failure to Power Up6
Patient problems
- No Clinical Signs, Symptoms or Conditions79
- No Patient Involvement28
- No Consequences Or Impact To Patient20
- Bacterial Infection2
- No Known Impact Or Consequence To Patient2
- Swelling/ Edema2
- Fistula1
- Fluid Discharge1
RENASYS TOUCH models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- RENASYS TOUCH 66801280Negative Pressure Wound Therapy Powered Suction Pump108 reports
- RENASYS TOUCH 66801273Negative Pressure Wound Therapy Powered Suction Pump12 reports
- RENASYS TOUCH 66801274Negative Pressure Wound Therapy Powered Suction Pump4 reports
- Renasys Touch 66801791Negative Pressure Wound Therapy Powered Suction Pump2 reports
Recent RENASYS TOUCH adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING NPWT FOR A DEHISCED TUMMY TUCK INCISION, UTILIZING A RENASYS F MEDIUM W/SOFT PORT, THE PATIENT MENTIONED THAT THE AREA AROUND THE HIPS WAS A BIT SWOLLEN, BUT THE WOUND WAS FEELING FINE AND WAS DRAINING WELL. IT WAS STATED THAT THE SWELLING THE PATIENT HAD MENTIONED WAS INDEPENDENT OF THE NPWT AND MORE A RESULT OF HOW THE SKIN HAD SETTLED AFTER THE OPERATION. IT WAS A COSMETIC ISSUE RATHER THAN ANYTHING ELSE. TREATMENT IS BEING PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE WOUND WAS SWABBED AND DETECTED PRESENCE OF BACTERIA SO THE PATIENT COMMENCED WITH AN ANTIBIOTIC TREATMENT.
Patient problems: Bacterial Infection; Swelling/ Edema
MAUDE report 13365347 ↗InjuryJan 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, DURING NPWT FOR A DEHISCED TUMMY TUCK INCISION, UTILIZING A RENASYS TOUCH DEVICE&POWER SUPPLY, THE PATIENT MENTIONED THAT THE AREA AROUND THE HIPS WAS A BIT SWOLLEN, BUT THE WOUND WAS FEELING FINE AND WAS DRAINING WELL. IT WAS STATED THAT THE SWELLING THE PATIENT HAD MENTIONED WAS INDEPENDENT OF THE NPWT AND MORE A RESULT OF HOW THE SKIN HAD SETTLED AFTER THE OPERATION. IT WAS A COSMETIC ISSUE RATHER THAN ANYTHING ELSE. TREATMENT IS BEING PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE WOUND WAS SWABBED AND DETECTED PRESENCE OF BACTERIA SO THE PATIENT COMMENCED WITH AN ANTIBIOTIC TREATMENT.
Patient problems: Bacterial Infection; Swelling/ Edema
MAUDE report 13365294 ↗InjuryNov 26, 2021Defective Alarm; Fluid/Blood Leak; Defective Alarm; Fluid/Blood Leak
IT WAS REPORTED THAT, DURING NPWT, A RENASYS TOUCH DEVICE&POWER SUPPLY NEVER ALARMED TO SHOW A LEAK, AND WHEN EXAMINED, THE FOOT WAS MACERATED. THE ADVANCED NURSE PRACTITIONER REPORTED THAT THERE WAS A POOLING OF FLUID UNDER THE PLANTER OF THE FOOT HOWEVER NO ALARM HAD ALERTED THEM THAT THERE WAS A LEAK. THE DRAPE WAS STILL INTACT HOWEVER FLUID HAD BUILT UP UNDERNEATH. THE PATIENT WAS ADMITTED INTO THE HOSPITAL, HAS STARTED ANTIBIOTICS, AND IS CURRENTLY NOT ON THE PUMP, SO TREATMENT WAS SUSPENDED. PATIENT HAD FURTHER DEBRIDEMENT, AND HAD USED AQUACEL ON THE PERIWOUND BEFORE APPLYING DUODERM.
Patient problems: Impaired Healing; Skin Disorders; Tissue Breakdown
MAUDE report 12878176 ↗MalfunctionSep 27, 2021Defective Alarm; Defective Alarm
IT WAS REPORTED THAT DURING SET UP FOR A NPWT PROCEDURE, A RENASYS TCH DEVICE&POWER SPLY DOES NOT REPORT AN ALARM IF THERE IS A LEAK. IT IS UNKNOWN HOW THERAPY WAS RESUMED. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12538023 ↗MalfunctionAug 3, 2021Failure to Charge; Overheating of Device; Failure to Charge; Overheating of Device
IT WAS REPORTED THAT, DURING WOUND TREATMENT, A RENASYS TOUCH DEVICE FAILED TO CHARGE WHEN PLUGGED IN. IN ADDITION, THE DEVICE WAS HOT TO TOUCH WHILE CHARGING. PATIENT HAD TO USE A FAN TO KEEP THE DEVICE COLD. TREATMENT WAS RESUMED WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12270737 ↗MalfunctionJun 30, 2021Overheating of Device; Overheating of Device
IT WAS REPORTED THAT A RENASYS TCH DEVICE&POWER SPLY WHEN DISCONNECTED FROM THE CURRENT IT APPEARED OVERHEATED AND STOPPED WORKING. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12097337 ↗MalfunctionJun 30, 2021Defective Alarm; Failure to Power Up; Defective Alarm; Failure to Power Up
IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE UNABLE TO START-UP CORRECTLY AND TO GENERATE ALARMS UNDER UNEXPECTED ALARM CONDITIONS DUE TO AN EMPTY COIN CELL AND A MISSING SOUND FILE. NO PATIENT HARMED, AND NO INJURY REPORTED BECAUSE THIS WAS FOUND DURING SERVICE AND REPAIR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12095985 ↗MalfunctionJun 24, 2021Defective Device; Defective Device
IT WAS REPORTED THAT DURING A NPWT UTILIZING A RENASYS TOUCH AND A RENASYS TOUCH 800ML CANISTER, AN ALARM FOR 'FULL' OCCURS EVEN THOUGH THE CANISTER IS NOT FULL. THIS PROBLEM WAS SOLVED BY REPLACING THE CANISTER. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12057881 ↗MalfunctionJun 16, 2021Failure to Power Up; Obstruction of Flow; Failure to Power Up; Obstruction of Flow
IT WAS REPORTED THAT, DURING NPWT, THE RENASYS TCH DEVICE&POWER SPLY WAS NOT ABLE TO RESTART AFTER IT WAS TURNED OFF DUE TO A BLOCKAGE WARNING. THE POWER BUTTON WAS NOT RESPONSIVE. THE NPWT WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12013051 ↗MalfunctionJun 2, 2021Infusion or Flow Problem; Suction Failure; Infusion or Flow Problem; Suction Failure
IT WAS REPORTED THAT THE RENASYS TCH DEVICE&POWER SPLY PRESENTED AND INTERNAL LEAK AND DURING SERVICE EVALUATION WAS CONFIRMED THAT DEVICE CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE. NO CASE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918478 ↗MalfunctionJun 2, 2021Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working
IT WAS REPORTED THAT THE BUTTON OF THE RENASYS TCH DEVICE&POWER SPLY WAS BROKEN. NO CASE INVOLVED; THEREFORE, NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918474 ↗MalfunctionJun 2, 2021False Alarm; False Alarm
IT WAS REPORTED THAT, DURING NPWT, THE RENASYS TCH DEVICE&POWER SPLY DISPLAYED A "COLLECTOR FULL" ALARM. WHEN CHECKED, THE COLLECTOR WAS COMPLETELY EMPTY, THERE WAS NO PROBLEM WITH THE TUBING AND THE DRESSING WAS WELL SEALED. THE DEVICE WAS STOPPED AND WHEN RESTARTING, A MESSAGE APPEARED ASKING FOR "MANUFACTURER MAINTENANCE". THE DEVICE WENT BACK TO THERAPY MODE WITHOUT ANY DIFFICULTY AND DID NOT ALARM AGAIN, THUS ALLOWING THE TREATMENT TO CONTINUE WITHOUT CHANGING THE MACHINE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11918466 ↗MalfunctionMay 27, 2021Defective Alarm; Obstruction of Flow; Defective Alarm; Obstruction of Flow
IT WAS REPORTED THAT, DURING NPWT WITH A RENASYS TOUCH. THE PUMP WAS DEFECTIVE BECAUSE THE ALARM DID NOT SOUND WHEN THE FOAM AND THE DRESSING WAS STUCK. THE TREATMENT WAS SUCCESSFULLY COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11892769 ↗MalfunctionMay 27, 2021Defective Alarm; Suction Problem; Obstruction of Flow; Defective Alarm; Suction Problem; Obstruction of Flow
IT WAS REPORTED THAT DURING NPWT, THE ALARM OF THE RENASYS TOUCH DID NOT SOUND WHEN THERE WERE SEALING PROBLEMS (FOR EXAMPLE WHEN THE FOAM AND THE DRESSING WERE UNSTUCK). THE PROCEDURE WAS COMPLETED USING AN S&N BACK-UP DEVICE. NO INJURY TO PATIENT REPORTED. NOTE: IT WAS USE AN UNK PART NUMBER DUE TO NON-EXISTENT PART NUMBER IN THE SYSTEM. THE TICKET TO SOLVE THE PROBLEM WAS CREATED. ONCE SOLVE, THE PART NUMBER WILL BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11892768 ↗InjuryMay 26, 2021Suction Failure; Suction Failure
IT WAS REPORTED THAT, DURING NPWT, THE RENASYS TCH DEVICE&POWER SPLY WAS NOT ABLE TO ACHIEVED A SEAL. THE DRESSINGS AND CANISTERS WERE CHANGE THREE TIMES BUT IT DID NOT SOLVED THE ISSUE. THE TREATMENT WAS COMPLETED WITH A COMPETITOR DEVICE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11891296 ↗
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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