RENASYS GO 66021496Recalls & reported problems

Summary

The FDA's MAUDE database contains 278 adverse event reports that list this exact device (DI 05000223491000), received between May 19, 2020 and Feb 10, 2025 — classified as 19 injuries, 259 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (56 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 278 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT, DURING A NPWT TREATMENT, THE PATIENT HAD TWO WOUNDS IN THE ABDOMEN, DUE TO THIS, IT WAS NECESSARY TO PLACE TWO (2) RENASYS F SMALL W/SOFT POR CONNECTED WITH ONE (1) RENASYS Y-CONNECTOR, AND THESE CONNECTED TO ONE (1) RENASYS GO. AT THE TIME OF PLACEMENT, APPARENTLY THE RENASYS DID NOT HAVE ENOUGH SUCTION CAPACITY SINCE IT SAID THERE WAS LEAK. THEY PLACED THE INDIVIDUAL RENASYS GO ON EACH FOAM, AND IT SEALED WELL, WITHOUT LEAKAGE, BUT THE SAME HAPPENED WHEN BOTH WERE PLACED SIMULTANEOUSLY. THEY CONFIRMED THAT THE Y CONNECTOR DID NOT HAVE ANY LEAKAGE. AS IT CONTINUED GIVING THE SAME ERROR, THEY PROCEEDED TO LEAVE ONLY ONE FOAM IN PLACE. THE NEXT DAY THERE WAS NO SUCTION, AND THE PATIENT'S ABDOMEN WAS A LITTLE SWOLLEN. THE DOCTOR PROCEEDED TO ENTER THE PATIENT INTO SURGERY TO DRAIN IT. NO DELAY OR FURTHER COMPLICATIONS WERE REPORTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS "STABLE".

  Patient problems: Swelling/ Edema

  MAUDE report 21351291 ↗
• MalfunctionSep 27, 2022Sparking; Sparking

  IT WAS REPORTED THAT A DURING NPWT A RENASYS GO HAD SPARKS COMING OUT OF THE POWER CORD WHEN IT WAS PLUGGED IN. NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED AS A CONSEQUENCE OF THIS PROBLEM. FURTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492251 ↗
• MalfunctionJul 11, 2022Arcing; Physical Resistance/Sticking; Arcing; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING WOUND THERAPY, A HEAD OF THE CHARGER OF A RENASYS GO WAS OBSERVED TO BE STUCK INSIDE. THE CUSTOMER STATED IT LOOKED "LIKE A TOILET PAPER ROLL" AND THAT SHE NOTICED WHEN SHE SAW A SPARK. IT IS UNKNOWN IF/HOW THERAPY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14980292 ↗
• MalfunctionMay 5, 2022Arcing; Arcing

  IT WAS REPORTED THAT, PATIENT NOTICED SPARKS WHERE THE POWER SOURCE PLUGS INTO THE RENASYS GO. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291690 ↗
• InjuryApr 28, 2022Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE USING THE RENASYS GO IT WAS ONLY FILLING 1 OUT 5 CANISTERS SUPPLIED. PATIENT WAS CONCERNED ABOUT RENASYS GO NOT DRAWING TO CANISTER AND A STRONG INFECTION, SMELL COMING FROM RENASYS GO. THE PATIENT TURNED RENASYS GO OFF AND WAS TOLD BY WOUND NURSE THAT SHE SHOULD NOT HAVE DONE THAT. PATIENT THEN SOUGHT MEDICAL ATTENTION AFTER RUNNING A FEVER AND NOT FEELING WELL WAS ADMITTED FOR INFECTION OF ONE OF HER WOUNDS. THERE WAS NO FLUID IN THE CANISTER OR TUBING. RENASYS GO WAS FUNCTIONING PROPERLY AND CANISTER WAS DRAWING THREW TUBING WITHOUT CONNECTION ON CAPPED AND HELD VACUUM WHEN CAPPED.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 14232600 ↗
• InjuryFeb 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING NPWT, THE RENASYS GO IS DISPLAYING A WARNING BLOCKAGE/CANISTER FULL. THE PATIENT INDICATED THAT HE UNDERWENT A DRESSING CHANGE AND CANISTER REPLACEMENT. HE ALSO STATE THAT HE HAD TO STOP USING THE RENASYS GO FOR TEN DAYS DUE TO THE DEVELOPMENT OF SKIN MACERATION; ESTIMATING THE THERAPY DISCONTINUATION TO BE (B)(6) 2022. THE WOUND IS LOCATED ON THE PATIENT'S FOOT AND IS DESCRIBED AS HAVING A "TINY NECK LESS THAN A 1CM OPENING AND 3CM IN LENGTH BUT WITH 1.5CM DEPTH". THE PATIENT DESCRIBED THE DRESSING AS BEING FIRM AND RAISIN-LIKE IN APPEARANCE. THE PATIENT WAS INSTRUCTED TO RESET THE DEVICE AND DISCONNECT AT THE QUICK CLICK CONNECTOR; BOTH RESULTING IN CONTINUOUS THERAPY BEING RE-STABLISHED. THE PATIENT WAS ENCOURAGED TO KEEP THE DEVICE IN AN UPRIGHT POSITION AS MUCH AS POSSIBLE RATHER THAN ALLOWING THE DEVICE TO LAY ON ITS BACK WITH ITS HEAD RAISE SLIGHTLY. THE PATIENT COMMENTED THAT HE HAS NEVER SEEN DRAINAGE IN THE TUBING OR THE CANISTER THROUGHOUT HIS THERAPY USE. INSTEAD HE REPORTED THAT THE DRESSING IS OFTEN SATURATED UPON CHANGING. THE PATIENT NOTED THAT THERE WAS ONLY ONE TIME WHERE A "SLIGHT HAZINESS OF WATER" WAS NOTED IN THE TUBING "BUT THAT O

  Patient problems: Skin Disorders

  MAUDE report 13577945 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD BEEN USING RENASYS GO FOR APPROXIMATELY 3 WEEKS WITHOUT ANY NOTABLE ISSUE, THEN WHEN A HEALTH CARE PROFESSIONAL VISITED THE PATIENT DISCOVERED THAT THERE WAS BLOOD ALL OVER THE FOOT THEREFORE DECIDED TO STOP THE USE OF THE DEVICE BECAUSE PATIENT'S FOOT WAS VERY MACERATED. PATIENT STATES THAT THE DEVICE DID NOT PRESET ANY WARNING SIGNS. WOUND IS CURRENTLY BEING TREATED WITH A CREAM AND A WET-TO-DRY DRESSING. NO OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Disorders

  MAUDE report 13515576 ↗
• MalfunctionJan 7, 2022Crack; Overheating of Device; Crack; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO DEVICE HAS A CRACKED HOUSING AND EMITS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13191974 ↗
• MalfunctionJan 4, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING NPWT, A RENASYS GO EMITS AN ODOR EVEN THOUGH THE CANISTER WAS CHANGED, IT IS ALSO MAKING A CLICKING NOISE AND THE BACK IS REALLY WARM. IT IS UNKNOWN HOW TREATMENT WAS RESUMED. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13152361 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO HAS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078807 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO HAS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078777 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO HAS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078728 ↗
• MalfunctionDec 23, 2021Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT, A RENASYS GO PRESENTED SMOKE SMELL. NO CASE INVOLVED; THEREFORE, NO PATIENT INJURIES OR OTHER COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078707 ↗
• MalfunctionDec 23, 2021Crack; Device Emits Odor; Overheating of Device; Crack; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT THE HOUSING OF A RENASYS GO IS CRACKED AND IT HAS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078643 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO HAS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-THERAPEUTIC ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078531 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO DEVICE EMITS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078107 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO DEVICE EMITS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078038 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO DEVICE IS EMITTING A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13078013 ↗
• MalfunctionDec 23, 2021Device Emits Odor; Overheating of Device; Device Emits Odor; Overheating of Device

  IT WAS REPORTED THAT A RENASYS GO DEVICE EMITS A SMOKE SMELL. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13077978 ↗
• InjuryNov 10, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT, DURING NPWT, A RENASYS GO DISPLAYED AN ALARM. TWO WEEKS AGO, PATIENT HAD EXPERIENCED IT BUT WAS NOT AWARE SO THE MACHINE STOPPED WORKING FOR TWO DAYS AND ENDED IN AN INFECTION. IT IS UNKNOWN HOW TREATMENT WAS COMPLETED. FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 12787398 ↗
• MalfunctionOct 1, 2021Overheating of Device; Protective Measures Problem; Overheating of Device; Protective Measures Problem

  IT WAS REPORTED THAT, AFTER WOUND TREATMENT WAS PERFORMED, THE LOWER END OF BATTERY INDICATOR OF A RENASYS GO DEVICE WAS ILLUMINING AN ORANGE LIGHT, THE ALARM WAS SOUNDING AND IT FAILED TO CHARGE. THE DEVICE FELT HOT, WHICH WAS SUSPECTED TO BE THE CAUSE OF THE CHARGING FAILURE. THIS ISSUE WAS RESOLVED BY UNPLUGGING THE DEVICE AND LETTING IT COOL DOWN FOR SOME MINUTES. AFTER THESE STEPS, THE DEVICE CHARGED CORRECTLY AND THE LIGHT TURNED GREEN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12564546 ↗
• MalfunctionSep 8, 2021Defective Alarm; Suction Problem; Defective Alarm; Suction Problem

  IT WAS REPORTED THAT BEFORE USE ON A PATIENT A RENASYS GO DEVICE IS NOT SUCTIONING PROPERLY, NO ALARMS, NO ADEQUATE SEAL. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12442528 ↗
• MalfunctionSep 8, 2021Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING NPWT, A RENASYS GO FELT WARM EVEN WHEN NOT PLUGGED IN. TREATMENT WAS RESUMED WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439917 ↗
• InjuryAug 30, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT, DURING NPWT, THE RENASYS GO PUMP WAS ALARMING "BLOCKAGE FULL". THE RENASYS GO CANISTER 300ML HAD LITTLE TO NO DRAINAGE AND CRYSTALS HAD RELEASED FROM SOLIDIFIER PACK INTO CANISTER. THE PUMP, THE DRESSING, AND THE CANNISTER WERE REPLACED, AND THE NEXT DAY THE ALARM SHOW OFF ON THE NEW RENASYS GO PUMP. PATIENTS WOUND SAT IN SECRETION AND PROGRESS TOWARDS HEALING TOOK A SETBACK. PATIENT WENT TO WOUND CLINIC AND THE NPWT WAS DISCONTINUED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Impaired Healing; Skin Disorders

  MAUDE report 12389217 ↗
• MalfunctionAug 30, 2021Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT, A RENASYS GO WAS NOT BEEPING OR DISPLAYING WARNINGS. PATIENT HAD SURGERY TO BIG TOE ON (B)(6) 2021, REPORTED IT WAS "NON-HEALING" PER HIS DOCTOR REQUIRING RENASYS GO DEVICE ON (B)(6) 2021. ON (B)(6) 2021 HE THOUGHT THERE WAS AN "OBVIOUS LEAK" IN HIS DRESSING AND IT WAS REPLACED THAT DAY: HIS DOCTOR SAID HE RECEIVED THERAPY, BECAUSE HE HADN'T HEARD ANY BEEPING THEN UNTIL NOW HE DIDN'T THINK HE'D RECEIVED THERAPY FOR 4 DAYS. FRUSTRATED HE WAS CALLING ABOUT IT FAILING TO ALERT HIM OF THE LEAK MONDAY AND WAS WORRIED IT WASN'T WORKING PROPERLY ASKED CURRENT STATUS OF DEVICE AND ANSWERED SINCE (B)(6) 2021 A GREEN LIGHT AND CONTINUOUS 120MMHG. STATED TO PATIENT THAT IT WAS WORKING AS EXPECTED AND HE'D RECEIVED THERAPY. PATIENT STILL QUESTIONING THAT THE HE HAD A LEAK ON MONDAY AND IT NEVER BEEPED. WALKED PATIENT THROUGH RESETTING THE DEVICE. STATED WOULD TROUBLE SHOOT AND HAVE A WARNING DISPLAY AND BEEP SO IT COULD BE CONFIRMED BY PATIENT AND HE WAS AGREEABLE. RESTARTED DEVICE, AFTER HAVING HIM UNPLUG IT FROM CHARGING, AND IT RETURNED TO CONTINUOUS SUCTION WITH GREEN LIGHT. UNCAPPED QUICK CLICK CONNECTOR AND CONTINUOUS 120 MMHG DISPLAYED. EXPLAINED DELIVERING THERAPY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12389079 ↗