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Renasys Touch 66801791Recalls & reported problems

Smith & Nephew Medical Limited · RENASYS TOUCH CONNECT Pump provides negative pressure therapy to a wound at a range of pressure settings via a tube set connected to a wound dressing. Pressure setting deliver setup is selectable via LCD screen. The suction pump creates negative pressure and removes exudate from the wound site to a disposable canister. The device can operate by either an external mains power supply or internal battery. The RENASYS TOUCH CONNECT pump has the facility to connect wirelessly to a cloud based system. Several accessories are available for use with the Pump including Canisters, Power supply either Class I or II, Carry Bag, Carry Strap and IV Pole/Bed Clamp. The Pump is suitable for use in both hospital and homecare settings. The Pump is compatible with existing Smith & Nephew Negative Pressure wound dressing kits on the market. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05000223490782), received between Oct 2, 2020 and Nov 3, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Alarm” (1 report).

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

Device problems

  • Defective Alarm1
  • Device Alarm System1
  • Failure to Charge1

Patient problems

  • No Consequences Or Impact To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 3, 2020Failure to Charge; Failure to Charge

    IT WAS REPORTED THAT THE RENASYS TOUCH DEVICE DOES NOT CHARGE THE BATTERY WHEN PLACED ON THE PATIENT AND SWITCHED ON. IT CHARGES ONLY AFTER BEING SWITCHED OFF FOR A LONG TIME. THERAPY CONTINUED WITH A BACK-UP DEVICES WITH NO DELAY. NO PATIENT HARM REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10781547 ↗
  • MalfunctionOct 2, 2020Device Alarm System; Defective Alarm; Device Alarm System; Defective Alarm

    IT WAS REPORTED THAT THE DEVICE HAS A FAULTY BATTERY WHICH IT STOPS PROVIDING CHARGE TO THE DEVICE, HOWEVER THE DEVICE CAN STILL BE OPERATED FROM THE CHARGER WITH AC POWER, BESIDES THE BATTERY FAILED ALARM IS NOT SHOWN. THE DEVICE KEEPS WORKING WITHOUT AN ALARM BUT WHEN THE AC CHARGER IS REMOVED THE DEVICE IMMEDIATELY SWITCHES OFF AS NO POWER IS PRESENT, WITHOUT SHOWING ANY ALARM. NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

    MAUDE report 10623348 ↗

Other Negative Pressure Wound Therapy Powered Suction Pump devices

All Negative Pressure Wound Therapy Powered Suction Pump devices →

Sources and updates

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