RENASYS TOUCH 66801274Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00040565126531), received between Jan 6, 2021 and Jun 24, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “False Alarm” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 13, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT DURING NPWT UTILIZING A RENASYS TOUCH AND CANISTER, AN ALARM FOR FULL OCCURRED EVEN THOUGH THE CANISTER WAS NOT FULL. THIS PROBLEM WAS SOLVED BY EXCHANGING THE CANISTER 3 TIMES. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED. 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 11817174 ↗
• MalfunctionJan 21, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT, WHILE USING RENASYS TOUCH CANISTERS 800 ML & 300 ML, IT WAS DISPLAYED IN THE SCREEN, CANISTER FULL TROUBLESHOOTING DESPITE NOT BEING PRACTICALLY FULL, DETECTED AFTER THE PROCEDURE WHICH LEAD TO PROCEDURE DELAY. OTHER CANISTER OF THE SAME BATCH WERE USED AND GAVE THE SAME TROUBLESHOOTING. THE PROCEDURE WAS FINISHED WITH A SMITH+NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11208054 ↗
• MalfunctionJan 6, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AFTER APPLYING AND ACTIVATING THE RENASYS SYSTEM, IT WAS FOUND THAT THE PRESSURE DID NOT REACH THE DRESSING. THE CUSTOMER REPLACED THE RESERVOIR AND EVERYTHING WAS WORKING NORMALLY. EVERYTHING INDICATES THAT THE RESERVOIR HAD AN OBSTRUCTION. NO HARM OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126049 ↗