RENASYS GO v2 HOME 66801496Recalls & reported problems

Summary

The FDA's MAUDE database contains 424 adverse event reports that list this exact device (DI 00040565126944), received between Sep 23, 2020 and Feb 1, 2022 — classified as 3 injuries, 421 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (286 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 424 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 1, 2022Failure to Charge; Overheating of Device; Failure to Charge; Overheating of Device

  IT WAS REPORTED THAT, DURING NPWT, THE RENASYS GO GAVE FAILURE IN THE CHARGING CONNECTION SECTION. IT SEEMED BURNED. TREATMENT WAS RESUMED, WITH A GREATER 30 MINUTES DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT HARMED, OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13407162 ↗
• MalfunctionOct 12, 2021Defective Alarm; Suction Failure; Defective Alarm; Suction Failure

  IT WAS REPORTED THAT A RENASYS GO FAIL BLOCKAGE TEST, NO DISPLAY OR AUDIBLE ALARM. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616274 ↗
• MalfunctionOct 5, 2021Defective Alarm; Break; Failure to Charge; Overheating of Device; Defective Alarm; Break; Failure to Charge; Overheating of Device

  IT WAS REPORTED THAT THE CASE OF A RENASYS GO BROKE. IN ADDITION THE DEVICE CAN´T OPERATE ON AC OR BATTERY POWER, CAN´T GENERATE AND CONTROL NEGATIVE PRESSURE, CAN´T GENERATE ALARMS UNDER EXPECTED CONDITIONS, AND THERE IS SIGNS OF ELECTRICAL OVERHEATING. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12578409 ↗
• MalfunctionSep 28, 2021Defective Alarm; Failure to Charge; Defective Alarm; Failure to Charge

  IT WAS REPORTED THAT, A RENASYS GO, DOES NOT ALARM AND DURING SERVICE EVALUATION WAS CONFIRMED THAT IT CANNOT OPERATE ON AC OR BATTERY POWER AND CANNOT RECHARGE THE BATTERY EITHER. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544535 ↗
• MalfunctionSep 27, 2021Defective Alarm; Failure to Charge; Crack; Defective Alarm; Failure to Charge; Crack

  IT WAS REPORTED THAT ONE RENASYS GO IS CRACKED AND HAS A DEFECTIVE MAINBOARD. DURING SERVICE AND REPAIR, THE DEVICE WAS FOUND TO BE UNABLE TO OPERATE ON AC OR BATTERY POWER AND DEVICE CANNOT START UP CORRECTLY AND IS NOT FREE FROM CRITICAL ERRORS, ALSO IT DOES NOT GENERATE ALARMS UNDER EXPECTED ALARM CONDITIONS. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538168 ↗
• MalfunctionSep 16, 2021Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT A RENASYS GO DON´T GENERATE ALARMS UNDER EXPECTED ALARM CONDITIONS. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12484024 ↗
• MalfunctionSep 8, 2021Defective Alarm; Failure to Charge; Suction Failure; Defective Alarm; Failure to Charge; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO, DID NOT OPERATE ON AC O BATTERY POWER AND CANNOT RECHARGE THE BATTERY. ALSO, THE DEVICE NEITHER GENERATE NOR CONTROL NEGATIVE PRESSURE. ALSO THE DEVICE DOES NOT GENERATE ALARMS UNDER EXPECTED ALARM CONDITIONS. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442649 ↗
• MalfunctionAug 3, 2021Defective Alarm; Failure to Charge; Suction Failure; Defective Alarm; Failure to Charge; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CANNOT OPERATE ON AC OR BATTERY POWER, AND CANNOT RECHARGE THE BATTERY EITHER. THE DEVICE NEITHER GENERATE NOR CONTROL NEGATIVE PRESSURE AND DO NOT GENERATE ALARMS UNDER EXPECTED ALARM CONDITIONS. AS THIS WAS NOTICED UPON SERVICE AND REPAIR ACTIVITIES, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12270750 ↗
• MalfunctionJun 29, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT A RENASYS GO DISPLAYED BLOCKAGE/CANISTER FULL ALARM. THE ISSUE WAS RESOLVED BY DISCONNECTING QUICK CLICK CONNECTORS. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12088994 ↗
• MalfunctionJun 24, 2021False Alarm; Device Displays Incorrect Message; False Alarm; Device Displays Incorrect Message

  IT WAS REPORTED THAT A RENASYS GO CONSOLE GENERATED A 'THERAPY STOP' ERROR MESSAGE INSTEAD OF A 'OBSTRUCTION / FULL CANISTER' ALERT. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058138 ↗
• MalfunctionJun 24, 2021Defective Alarm; Obstruction of Flow; Defective Alarm; Obstruction of Flow

  IT WAS REPORTED THAT RENASYS GO GENERATED A 'THERAPY STOP' ERROR MESSAGE INSTEAD OF A 'OBSTRUCTION/ FULL CANISTER' MESSAGE. AS THIS WAS NOTICED UPON A TESTING PROCEDURE, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058131 ↗
• MalfunctionJun 24, 2021Suction Problem; Suction Problem

  IT WAS REPORTED THAT ON JUNE 4TH A RENASYS GO DEVICE STARTED DISPLAYING A LOW VACUUM WARNING. AFTER PERFORMING SOME TROUBLESHOOTING (RESETTING THE DEVICE, SMOOTHING DOWN THE ADHESIVE EDGES, DISENGAGING THE QUICK CLICK CONNECTOR, REPOSITIONING THE CANISTER AND ADDING SOME ADHESIVE) CONTINUOUS 120MM HG VACUUM THERAPY RESUMED BUT THEN, THE NURSE NOTICED THAT THE DEVICE WAS NOT SUCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12058129 ↗
• MalfunctionJun 22, 2021Defective Alarm; Device Displays Incorrect Message; Defective Alarm; Device Displays Incorrect Message

  IT WAS REPORTED ON JUNE 8TH, DURING TESTING, A RENASYS GO DEVICE GENERATING A THERAPY STOP ERROR MESSAGE INSTEAD OF A OBSTRUCTION/FULL CANISTER MESSAGE. NO PATIENT IS INVOLVED IN THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041798 ↗
• MalfunctionJun 16, 2021Crack; Device Emits Odor; Defective Component; Suction Failure; Crack; Device Emits Odor; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE PUMP HAD ODOR, REQUIRES A PPM (DIAPHRAGM PUMP REPLACEMENT) AND THE CASE WAS CRACKED. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012850 ↗
• MalfunctionJun 16, 2021Crack; Defective Component; Suction Failure; Crack; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE PUMP REQUIRES A PPM (DIAPHRAGM PUMP REPLACEMENT) AND THE CASE WAS CRACKED. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012831 ↗
• MalfunctionJun 16, 2021Defective Component; Suction Failure; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE PUMP REQUIRES A PPM (DIAPHRAGM PUMP REPLACEMENT). AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12012770 ↗
• MalfunctionJun 10, 2021Crack; Defective Component; Suction Failure; Crack; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE DEVICE REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT) AND THE CASE WAS CRACK. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979258 ↗
• MalfunctionJun 10, 2021Crack; Device Emits Odor; Defective Component; Suction Failure; Crack; Device Emits Odor; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE DEVICE HAD ODOR, REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT) AND THE CASE WAS CRACK. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979198 ↗
• MalfunctionJun 9, 2021Failure to Charge; Crack; Defective Component; Suction Failure; Failure to Charge; Crack; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE, CAN'T OPERATE ON AC OR BATTERY POWER, AND CAN'T RECHARGE THE BATTERY; IT WAS ALSO FOUND THAT THE DEVICE REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT) AND THE CASE WAS CRACK. AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970929 ↗
• MalfunctionJun 9, 2021Defective Component; Suction Failure; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE DEVICE REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT). AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970586 ↗
• MalfunctionJun 9, 2021Device Emits Odor; Defective Component; Suction Failure; Device Emits Odor; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE, CAN'T OPERATE ON AC OR BATTERY POWER, AND CAN'T RECHARGE THE BATTERY; IT WAS ALSO FOUND THAT THE PUMP HAD ODOR AND REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT). AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11970470 ↗
• MalfunctionJun 4, 2021Crack; Suction Failure; Crack; Suction Failure

  IT WAS REPORTED THAT THE RENASYS GO CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE AND THE CASE IS CRACKED. AS THIS HAPPENED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939386 ↗
• MalfunctionJun 4, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RENASYS GO CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS HAPPENED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939214 ↗
• MalfunctionJun 4, 2021Defective Component; Suction Failure; Defective Component; Suction Failure

  IT WAS REPORTED THAT, A RENASYS GO CAN'T GENERATE AND CONTROL NEGATIVE PRESSURE; IT WAS ALSO FOUND THAT THE DEVICE REQUIRED A PPM (DIAPHRAGM PUMP REPLACEMENT). AS THIS WAS NOTICED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939182 ↗
• MalfunctionJun 4, 2021Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RENASYS GO CANNOT GENERATE AND CONTROL NEGATIVE PRESSURE. AS THIS HAPPENED DURING SERVICE AND REPAIR ACTIVITIES, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939081 ↗