RENASYS TOUCH 66801280Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00040565126586), received between Sep 28, 2020 and Jan 27, 2022 — classified as 8 injuries, 100 malfunctions.

The most frequently reported specific device problem is “Failure to Charge” (42 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 25 most recent of 108 reports, 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 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 ↗
• MalfunctionMay 26, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT, A RENASYS TCH DEVICE&POWER SPLY WAS COLLECTED BACK FROM CUSTOMER CLINIC AND FOUND THAT THE ¿PLAY/PAUSE¿ BUTTON IS FAULTY. CANNOT START THE THERAPY. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882908 ↗
• MalfunctionMay 24, 2021Dent in Material; Suction Failure; Dent in Material; Suction Failure

  IT WAS REPORTED THAT THE RENASYS TCH DEVICE&POWER SPLY HAS VISIBLE DENTS AND CAN´T GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11873884 ↗
• MalfunctionMay 19, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT, DURING TREATMENT, A RENASYS TCH DEVICE&POWER SPLY WILL NOT SUCTION AT ALL. THE TREATMENT WAS COMPLETED, WITH A DELAY LESS THAN 30 MIN, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846720 ↗
• MalfunctionMay 19, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RENASYS TCH DEVICE&POWER SPLY DEVICE CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846717 ↗
• MalfunctionMay 19, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RENASYS TCH DEVICE&POWER SPLY DEVICE CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11846713 ↗
• MalfunctionMay 12, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT, A RENASYS TCH DEVICE&POWER SPLY COULD NOT GENERATE AND CONTROL NEGATIVE PRESSURE AND ALSO HAD VISIBLE DENTS. AS THIS WAS NOTICE IN A SERVICE AND REPAIR, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812441 ↗
• MalfunctionMay 11, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RENASYS TCH DEVICE&POWER SPLY CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809734 ↗
• MalfunctionMay 10, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT DURING SERVICE EVALUATION IT WAS NOTICED THAT THE RENASYS TCH DEVICE&POWER SPLY HAD VISIBLE DENTS AND THE ATTACHMENT KNOB WAS MISSING. ADDITIONALLY, THE DEVICE WAS NOT ABLE TO GENERATE AND CONTROL NEGATIVE PRESSURE. THE DEVICE FAILED THE BLOCKAGE TEST. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11802904 ↗
• MalfunctionMay 6, 2021Failure to Power Up; Defective Component; Failure to Power Up; Defective Component

  IT WAS REPORTED THAT THE ¿ON¿ BUTTON AT THE FRONT PANEL OF A RENASYS TOUCH DEVICE IS NOT WORKING AND WAS UNABLE TO POWER PUMP ON. AS THIS WAS NOTICED DURING SERVICING / PREVENTATIVE MAINTENANCE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787985 ↗
• MalfunctionMay 6, 2021Failure to Calibrate; Suction Failure; Failure to Calibrate; Suction Failure

  IT WAS REPORTED THAT DURING SERVICE EVALUATION IT WAS NOTICED THAT THE RENASYS TCH DEVICE WAS NOT ABLE TO GENERATE AND CONTROL NEGATIVE PRESSURE. ADDITIONALLY THE DEVICE CANNOT BE CALIBRATED. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787887 ↗
• MalfunctionMay 6, 2021Failure to Charge; Defective Component; Failure to Charge; Defective Component

  IT WAS REPORTED THAT, IN A SERVICE CENTER, A RENASYS TCH DEVICE&POWER SPLY THE KEYBOARD LOCK DOES NOT WORK AND CAN NOT OPERATE ON AC OR BATTERY POWER, AND CAN NOT RECHARGE THE BATTERY. AS THIS AS NOTICE IS A SERVICE AND REPAIR, NOT PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787881 ↗