RENASYS TOUCH 66801273Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00040565126524), received between Nov 2, 2020 and May 13, 2021 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “False Alarm” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2021Difficult to Open or Close; Sharp Edges; Difficult to Open or Close; Sharp Edges

  IT WAS REPORTED THAT WHEN CHANGING THE CANISTER, THE RENASYS TCH 300ML CANISTER WAS VERY DIFFICULT TO OPEN AND THE TAPS WERE VERY SHARP. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. THE NURSE CUT HIMSELF WHEN OPENING THE CANISTER TABS. NO OTHER COMPLICATIONS REPORTED.

  Patient problems: Localized Skin Lesion

  MAUDE report 11822012 ↗
• MalfunctionMay 12, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING NPWT, THE RENASYS TCH 300ML CANISTER ABSORPTION PACKET BURST AND CAUSED A BLOCKAGE. THERE WAS MINIMAL EXUDATE IN THE CANISTER WHEN THE PACKET BURST. THE TREATMENT WAS CONTINUED USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813743 ↗
• InjuryMay 12, 2021Difficult to Open or Close; Sharp Edges; Difficult to Open or Close; Sharp Edges

  IT WAS REPORTED THAT, BEFORE NPWT WITH FIVE (5) RENASYS TCH 300ML CANISTER. WHEN CHANGING THE CANISTER, THE TWO ORANGE TABS ON THE SIDE OF THE CANISTER WERE VERY DIFFICULT TO OPEN, SO THE NURSE CUT HIMSELF ON THE FINGER WHEN OPENING THE CANISTER TABS AS THE TABS WERE VERY SHARP. THE NURSE WAS FINE AND THE SMALL CUT WAS ONLY PUT ON WITH A PLASTER AND HAS HEALED WELL IN THE MEANTIME. THE TREATMENT WAS SUCCESSFULLY COMPLETED WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Needle Stick/Puncture

  MAUDE report 11813624 ↗
• 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 11208074 ↗
• 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 11208055 ↗
• MalfunctionJan 6, 2021False Alarm; False Alarm

  IT WAS REPORTED THAT THE RENASYS TOUCH DEVICE DISPLAYED A "CANISTER FULL" ALARM WITHOUT BEING SO. THE CANISTER WAS EXCHANGED BUT THE ISSUE WAS NOT SOLVED. THE SEALING SYSTEM IS MODIFIED AND IT KEEPS FAILING. THIS HAPPENED TWICE, ON WEDNESDAY 12/9, AGAIN ON FRIDAY 12/11 AND THE LAST TIME ON MONDAY 12/14. WHEN CANISTERS FROM NEW BATCHES WERE PLACED THE ALARM RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11126194 ↗
• MalfunctionDec 22, 2020False 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 SOLVED BY EXCHANGING THE CANISTER. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH-NEPHEW BACK UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE 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 11055354 ↗
• MalfunctionNov 18, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT THERE HAVE BEEN PROBLEMS WITH THE NEW CANISTERS BECAUSE THE BAG BURSTS WHEN THERE ARE VERY FEW SEROSITIES IN THE CANISTER. SOLIDIFYING PLUGS THE SUCTION PORT CAUSING THE PUMP TO ALARM AT NIGHT. THE NURSES HAVE TO TRAVEL FOR THIS REASON AND WE WASTE CONSUMABLES SO THE SUPPLY IS JUST-IN-TIME.

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

  MAUDE report 10859747 ↗
• MalfunctionNov 18, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT THERE HAVE BEEN PROBLEMS WITH THE NEW CANISTERS BECAUSE THE BAG BURSTS WHEN THERE ARE VERY FEW SEROSITIES IN THE CANISTER. SOLIDIFYING PLUGS THE SUCTION PORT CAUSING THE PUMP TO ALARM AT NIGHT. THE NURSES HAVE TO TRAVEL FOR THIS REASON AND WE WASTE CONSUMABLES SO THE SUPPLY IS JUST-IN-TIME.

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

  MAUDE report 10859746 ↗
• MalfunctionNov 18, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT THERE HAVE BEEN PROBLEMS WITH THE NEW CANISTERS BECAUSE THE BAG BURSTS WHEN THERE ARE VERY FEW SEROSITIES IN THE CANISTER. SOLIDIFYING PLUGS THE SUCTION PORT CAUSING THE PUMP TO ALARM AT NIGHT. THE NURSES HAVE TO TRAVEL FOR THIS REASON AND WE WASTE CONSUMABLES SO THE SUPPLY IS JUST-IN-TIME.

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

  MAUDE report 10859745 ↗
• MalfunctionNov 11, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT THE RENASYS TOUCH DEVICE GIVES A "CONTAINER FULL" ALARM WITHOUT BEING SO. THEY PUT IN A NEW 300 ML CONTAINER AND THE DEVICE KEEPS GIVING THE SAME ALARM, THEY MODIFY THE CURE, THE SEALING SYSTEM AND IT KEEPS FAILING. THIS HAPPENS TWICE, ON FRIDAY THE 16TH AND AGAIN ON MONDAY THE 19TH. IT MUST BE BECAUSE BOTH THE 300ML CONTAINERS AND THE RENASYS SEALING KITS ARE NOT FROM OPTIMIZED BATCHES. WE PLACE NEW OPTIMIZED BATCHES AND THERE ARE NO ALARMS. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY GREATER THAN 30 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10821125 ↗
• MalfunctionNov 2, 2020Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT DURING NPWT UTILIZING RENASYS TOUCH, THE MESSAGE OF BLOCKAGE ALARM WAS DISPLAYED ON THE SCREEN; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10770189 ↗