RENASYS GORecalls & reported problems across all models

We found 3 models of RENASYS GO by Smith & Nephew Medical Limited in the FDA's device registry (GUDID). Together they are named in 280 adverse event reports in the FDA's MAUDE database, received between May 19, 2020 and Feb 10, 2025 — classified as 19 injuries, 261 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RENASYS GO problems

RENASYS GO models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RENASYS GO 66021496

  Negative Pressure Wound Therapy Powered Suction Pump
  278 reports
• RENASYS GO 66800603

  Negative Pressure Wound Therapy Powered Suction Pump
  1 report
• RENASYS GO 66020914

  Negative Pressure Wound Therapy Powered Suction Pump
  1 report

Recent RENASYS GO adverse event reports

The 15 most recent reports across all models, 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 ↗

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