RENASYS TOUCH DEVICE & POWER SUP 66801281Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 05000223494476), received between Nov 10, 2020 and May 5, 2022 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “False Alarm” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2022Device Handling Problem; Device Handling Problem

  IT WAS REPORTED THAT, DURING WOUND THERAPY, THE PATIENT EXPERIENCED VEIN BLEEDING WHILE USING A RENASYS TOUCH DEVICE. THE DEVICE WAS USED IN EXPOSED AREAS OF THE INTESTINAL TRACT IN SPITE OF THE INSTRUCTIONS FOR USE INDICATING IT SHOULD NOT BE APPLIED IN SUCH CIRCUMSTANCES. THIS ADVERSE EVENT WAS TREATED BY PERFORMING HEMOSTASIS AND BY DISCONTINUING NPWT. TREATMENT WITH GAUZE WAS APPLIED INSTEAD. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14288763 ↗
• MalfunctionJun 29, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, DURING NPWT, A RENASYS TOUCH DEVICE FAILED BY DISPLAYING BLOCKAGE ALARM ON THE SCREEN; A SMALL NPWT FOAM FILLER KIT WAS BEING USED WHEN THE FAILURE OCCURRED. TREATMENT WAS PERFORMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. FAILURE WAS CATEGORIZED AS OUT-OF-THE-BOX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089012 ↗
• MalfunctionJun 24, 2021No Audible Alarm; Alarm Not Visible; No Audible Alarm; Alarm Not Visible

  IT WAS REPORTED THAT ON JUNE 9TH, DURING NPWT USING RENASYS TOUCH DEVICE ON A SACRAL WOUND, THE DRESSING BECAME LOOSE (FOAM WAS VISUALLY ABLE TO BE SEEN, THE SEAL WAS LOST) BUT THE PUMP WAS NOT REGISTERING ANY AIR LEAK. THE PUMP STARTED RAMPING UP (AS IT TYPICALLY WOULD WHEN ATTEMPTING TO ACHIEVE A SEAL) BUT THE LIGHT WAS STILL GREEN ON PUMP AND NO ALARM WAS GOING OFF. WHEN CLINICIAN CHECKED THE FLOW METER, THE FLOW WAS POSITIVE, INDICATING THAT THE SEAL WAS LOST. AFTER CLINICIAN FIXED DRESSING, THE PUMP CONTINUED TO WORK APPROPRIATELY. PUMP WAS SWITCHED OUT FOLLOWING DAY TO BE CAUTIOUS. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059097 ↗
• MalfunctionJun 22, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, DURING A NPWT TREATMENT, A RENASYS TOUCH DEVICE & POWER SUP DISPLAYED A BLOCKAGE ALARM MESSAGE ON THE SCREEN AFTER CHANGING THE CANISTER AND RESUMING TREATMENT. THE PROBLEM WAS NOT SOLVED BY EXCHANGING THE CANISTER. THE TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042503 ↗
• MalfunctionJun 22, 2021Obstruction of Flow; Protective Measures Problem; Obstruction of Flow; Protective Measures Problem

  IT WAS REPORTED THAT, DURING TREATMENT, A RENASYS TOUCH DEVICE & POWER SUP A BLOCKAGE ALARM OCCURRED, THE CANISTER WAS EXCHANGED. WHEN YOU TURN ON THE DEVICE, THE MESSAGE OF "808B" WAS DISPLAYED ON THE SCREEN. TREATMENT WAS RESUMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12042022 ↗
• MalfunctionJun 22, 2021Failure to Power Up; Defective Component; Failure to Power Up; Defective Component

  I WAS REPORTED THAT A RENASYS TOUCH DEVICE & POWER SUP DID NOT STARTED WHEN THE POWER BUTTON WAS PRESSED. THIS PROBLEM WAS REPAIRED BY REPLACING THE MAIN PCB. A MAINTENANCE PROGRAM WAS ALSO IMPLEMENTED. AFTER ALL THIS PROCEDURES WERE PERFORMED THE DEVICE STARTS-UP CORRECTLY AND IS FREE FROM CRITICAL ERRORS. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041838 ↗
• MalfunctionJun 16, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING NPWT WITH A RENASYS TOUCH DEVICE & POWER SUP, IMMEDIATELY AFTER CHANGING THE CANISTER AND RESUMING TREATMENT, THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN. THE PROBLEM WAS NOT SOLVED BY EXCHANGING THE CANISTER. THE TREATMENT WAS RESUME WITH A SMITH AND NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012691 ↗
• MalfunctionMay 31, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING NPWT WITH A RENASYS TOUCH DEVICE & POWER SUP, IMMEDIATELY AFTER CHANGING THE DRESSING AND RESUMING TREATMENT, THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN. THE PROBLEM WAS NOT SOLVED BY EXCHANGING THE CANISTER. THE TREATMENT WAS CONTINUED WITH A BACK-UP DEVICE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11910647 ↗
• MalfunctionMay 31, 2021Defective Component; Defective Component

  IT WAS REPORTED THAT DURING TREATMENT A RENASYS TOUCH DEVICE & POWER SUP, THE POWER BUTTON DID NOT RESPOND. THE TREATMENT WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11907487 ↗
• MalfunctionMay 27, 2021Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT DURING NPWT, A BLOCKAGE OCCURRED WHEN THE RENASYS TOUCH DEVICE & POWER SUP WAS BEING USED. THE PROBLEM WAS THAT THE BLOCKAGE ALARM DID NOT ACTIVATED WHEN THIS HAPPENED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892774 ↗
• MalfunctionMay 27, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT DURING NPWT, AFTER CHANGING THE DRESSING, THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN OF THE RENASYS TOUCH DEVICE & POWER SUP. THE CANISTER WAS CHANGED, BUT THE PROBLEM PERSISTED. THE TREATMENT WAS FINISHED USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11892767 ↗
• MalfunctionMay 6, 2021Break; Break

  IT WAS REPORTED THAT THE RENASYS TOUCH DEVICE & POWER SUP HAD A BROKEN POWER BUTTON. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11787897 ↗
• MalfunctionApr 28, 2021Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER CHANGING THE DRESSING AND RESUMING TREATMENT, IN THE RENASYS TOUCH DEVICE & POWER SUP THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN. THE PROBLEM WAS NOT SOLVED BY EXCHANGING THE CANISTER. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741320 ↗
• MalfunctionApr 21, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING A NPWT A RENASYS TOUCH DEVICE & POWER SUP, DISPLAY A MESSAGE OF "808A". IN ADDITION PROBLEM WAS NOT SOLVED BY REMOVING THE DEVICE FROM THE CANISTER AND REBOOT. THE TREATMENT WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700392 ↗
• InjuryApr 2, 2021Computer Software Problem; Computer Software Problem

  IT WAS REPORTED THAT WHEN THE DEVICE IS TURNED ON, THE MESSAGE OF SMITH & NEPHEW WAS DISPLAYED ON THE SCREEN. HOWEVER, THE DEVICE STOPPED WORKING. THE TREATMENT WAS STARTED WITH A BACK-UP DEVICE. THERE WAS NO PATIENT HARM. IT TOOK 3 HOURS TO RESUME TREATMENT. THE DOCTOR TREATED WITH GAUZE UNTIL THE REPLACEMENT. THE DEVICE WILL BE RETURNED TO JP LOCAL SERVICE FOR EVALUATION. THE RESULTS SHARED AFTER ITS COMPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11609478 ↗
• MalfunctionMar 16, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING NPWT UTILIZING A RENASYS TOUCH, THE DRESSING WAS NOT COMPRESSED, AND IT WAS NOT CONFIRMED THAT THE SPONGE OF IN THE SOFTPORT WAS DAMAGED. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM. THE TREATMENT WAS CONTINUED WITH A THE BACK-UP DEVICE. THE CANISTER AND SOFTPORT WERE DISCARDED AND THE LOT NUMBER COULD NOT BE CONFIRMED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492362 ↗
• MalfunctionMar 7, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT, DURING TREATMENT, WHEN CHANGING THE DRESSING AND RESUMING TREATMENT, RENASYS TOUCH DEVICE SHOWED THE MESSAGE OF THE CANISTER FULL ALARM DISPLAYED ON THE SCREEN. THE TREATMENT WAS COMPLETED WITHOUT DELAY USING A SMITH & NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11429771 ↗
• MalfunctionFeb 26, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A TUBE OF THE RENASYS PUMP HAS A BLOCKAGE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11384769 ↗
• MalfunctionFeb 15, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT DURING NPWT UTILIZING A RENASYS TOUCH AND CANISTER, AN ALARM FOR FULL OCCURS EVEN THOUGH THE CANISTER IS NOT FULL. THIS PROBLEM WAS NOT SOLVED BY EXCHANGING THE CANISTER. THIS PROBLEM WAS SOLVED BY EXCHANGING THE DEVICE. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11327911 ↗
• MalfunctionFeb 4, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT DURING TREATMENT, THE PUMP FAILED AND COULD NOT BE TURNED BACK ON. IT IS UNKNOWN IF THERE WAS A BACKUP AVAILABLE TO CONTINUE WITH THE TREATMENT. NO PATIENT HARM WAS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11282575 ↗
• MalfunctionFeb 1, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ON THE 2ND DAY OF NPWT UTILIZING A RENASYS TOUCH, IT WAS CONFIRMED THE DEVICE WAS ABNORMALLY HEATING. THE TREATMENT WAS CONTINUED BY EXCHANGING THE DEVICE. NO PATIENT HARM. NO INFORMATION ABOUT DELAY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11258982 ↗
• MalfunctionJan 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, THE PATIENT DIED WHILE USING RENASYS TOUCH. IT WAS BEING USED TO TREAT A LEG WOUND, 1500 ML OF EXUDATE WAS CONFIRMED AND THE USE OF RENASYS TOUCH WAS DISCONTINUED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 11232702 ↗
• MalfunctionJan 23, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT, DURING NPWT UTILIZING A RENASYS TOUCH, THE MESSAGE OF "808A" DISPLAYED ON THE SCREEN. THE PROBLEM WAS NOT SOLVED BY REMOVING THE DEVICE FROM THE CANISTER AND REBOOT. THE TREATMENT WAS CONTINUED WITH A SMITH+NEPHEW BACK-UP DEVICE. THERE WAS NO PATIENT HARM. THERE WAS NO DELAY. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11220181 ↗
• MalfunctionJan 15, 2021Obstruction of Flow

  IT WAS REPORTED THAT WHEN CHANGING THE DRESSING AND RESUMING TREATMENT WITH RENASYS TOUCH, THE MESSAGE OF THE CANISTER FULL ALARM WAS DISPLAYED ON THE SCREEN. THIS PROBLEM WAS SOLVED BY EXCHANGING THE DEVICE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11181376 ↗
• MalfunctionJan 14, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT IMMEDIATELY AFTER CHANGING THE DRESSING AND RESUMING TREATMENT, THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN. THE PROBLEM WAS NOT SOLVED BY EXCHANGING THE DEVICE. THERE WAS NO DELAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11171423 ↗