Avive AED with Avive Connect AED01Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00860002508559), received between May 15, 2024 and Sep 9, 2026 — classified as 2 deaths, 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Failure to Sense” (4 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Failure to Sense

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50701746 ↗
• InjuryAug 14, 2026Failure to Sense

  The user reported that the AED had been used the week prior on June 21st and had no issues. The same AED was used on a patient on (b)(6) for which the user reported that the pads were placed but the AED was giving an error message by saying pads were not connected. Staff redid the pad cartridge installation but the AED still was giving error message.We are considering this to be a serious injury due to life-saving therapy/treatment may have been delayed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50245308 ↗
• InjuryMay 11, 2026Patient Device Interaction Problem

  THE USER REPORTED THAT ADDITIONAL STAFF MEMBERS PRESENT AT THE INCIDENT PEELED AND PREPARED THE PADS AFTER A TRAY PULL, WHILE THE USER PERFORMED CPR. THE USER REMOVED THE PATIENT'S CLOTHING AND APPLIED THE ELECTRODE PADS. THE USER STATED THAT THE PATIENT HAD A HAIRY CHEST AND WHILE A RAZOR WAS AVAILABLE IN A SEPARATE POUCH, THE USER WAS UNAWARE AT THE TIME THAT THE PATIENT'S CHEST NEEDED TO BE SHAVED. THE USER STATED THAT THE AED DIDN'T WORK AND THE ONLY AUDIBLE PROMPT THAT HE RECALLED HEARING FROM THE DEVICE WAS "POWERED ON". WE ARE CONSIDERING THIS TO BE A SERIOUS INJURY DUE TO LIFE-SAVING THERAPY/TREATMENT MAY HAVE BEEN DELAYED.

  Patient problems: Cardiac Arrest

  MAUDE report 25136398 ↗
• MalfunctionMay 8, 2026Device Sensing Problem

  USER REPORTED THAT THE AED PADS WERE APPLIED TO THE PATIENT, HOWEVER, THE DEVICE NEVER DETECTED THE PATIENT. PER THE USER, THE DEVICE KEPT REQUESTING PADS TO BE PLACED ON PATIENT.

  Patient problems: Cardiac Arrest

  MAUDE report 25130559 ↗
• MalfunctionMar 9, 2026No Audible Prompt/Feedback

  WHILE PERFORMING ROUTINE MAINTENANCE, A USER REPORTED THAT THE AUDIO ON HIS AED WAS NOT WORKING. THE USER ATTEMPTED TO PERFORM A MANUAL STATUS CHECK AND PRESS THE AED POWER BUTTON, NEITHER OF WHICH HAD ANY AUDIO WHEN TRIGGERED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553184 ↗
• InjuryFeb 25, 2026Device Difficult to Setup or Prepare

  GYM MEMBER USED THE AED OUTSIDE OF NORMAL BUSINESS HOURS ON ANOTHER GYM MEMBER AND REPORTED THAT THERE WERE NO PADS WHEN TRYING TO USE THE AED. LOCAL MANAGER LATER ONSITE SAW AND CONFIRMED THE PADS WERE IN THE AED DEVICE AND PROVIDED PHOTO OF THE DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 24444561 ↗
• MalfunctionFeb 6, 2026Failure to Sense

  USER REPORTED THAT DURING A CARDIAC ARREST EMERGENCY USE, WHEN ATTEMPTING TO APPLY PADS, THE DEVICE REPEATEDLY INDICATED THAT THE PATIENT WAS NOT DETECTED. USER STATED THE PATIENT WAS DRY, WITH NO EXCESSIVE BODY HAIR OR OTHER OBVIOUS IMPEDIMENTS TO PAD PLACEMENT.

  Patient problems: Cardiac Arrest

  MAUDE report 24284839 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  CUSTOMER REPORTED "WHEN I PULLED THE AED PADS FROM MY AVIVE AED, THEY NEVER ACTIVATED AND IT NEVER RECOGNIZED THAT I HAD APPLIED THEM. ANOTHER CARE TEAM MEMBER ARRIVED JUST AFTER ME SO WE USED ANOTHER AVIVE AED AND IT WORKED AND SHOCKED THE PATIENT."

  Patient problems: Cardiac Arrest

  MAUDE report 23864208 ↗
• InjuryNov 26, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  CUSTOMER ATTEMPTED TO USE AVIVE AED DEVICE IN AN EMERGENCY BUT WERE HAVING TROUBLE WITH THE PAD CARTRIDGE. USER REPORTED THAT THE PAD CARTRIDGE WAS RECOGNIZED BY THE AED AND WALKED THEM UP TO THE "PLACE PADS ON PATIENT" STEP BUT THE PADS WOULD NOT TAKE A READING ON THE PATIENT AS THEY DID NOT SHAVE THE PATIENT AND THE PADS WERE NOT COMING IN CONTACT WITH SKIN. EMS ARRIVED ON SCENE BEFORE A READING COULD BE TAKEN AND TOOK OVER FROM THERE. STATUS OF THE PATIENT IS UNKNOWN AT THIS TIME.

  Patient problems: Cardiac Arrest

  MAUDE report 23658970 ↗
• MalfunctionDec 10, 2024Electrical /Electronic Property Problem; Failure of Device to Self-Test; Electrical /Electronic Property Problem; Failure of Device to Self-Test

  CUSTOMER CALLED IN STATING HER AED HAD A RED STATUS LIGHT AND "FAILED AED SELF TEST" FOR THE SECOND TIME. FIRST TIME OCCURRED EARLY SEPTEMBER. CUSTOMER SERVICE WAS ABLE TO ASSIST THE CUSTOMER IN GETTING THE DEVICE BACK IN WORKING ORDER BUT TO CALL BACK IF THE ISSUE RECURRED. CUSTOMER CALLED AGAIN AND STATED THE DEVICE FAILED A SELF TEST AGAIN AND GIVES THE MESSAGE: "DEVICE CANNOT BE USED, MUST BEGIN CPR". UPON INVESTIGATION OF THE DEVICE, IT WAS DISCOVERED THAT THE DEVICE FAILED AN INTERNAL SELF-TEST AFTER IDENTIFYING A POTENTIALLY CORRUPTED AUDIO FILE. IN AN EMERGENCY, A CORRUPTED AUDIO FILE MAY NOT BE ABLE TO PLAY AUDIO PREVENTING THE AED FROM PROVIDING THE USER WITH CRITICAL LIFE SAVING OR SAFETY INSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898429 ↗
• MalfunctionNov 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  CUSTOMER CALLED IN SAYING THEIR AED WILL NOT CHARGE. THEY HAD IT PLUGGED IN FOR ABOUT TWO WEEKS. THE SCREEN DOES NOT TURN ON AND THE AED DOES NOT TURN ON EITHER. WHEN THE CUSTOMER PLUGGED IN THE DEVICE, THE AED FLASHED RED FOR A SECOND. UPON UNPLUGGING AND REPLUGGING IN, THE DEVICE DID NOT FLASH. ADDITIONALLY, THE AED WAS UNRESPONSIVE WHEN PERFORMING A STATUS CHECK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736880 ↗
• MalfunctionNov 6, 2024Failure to Charge; Failure to Charge

  CUSTOMER'S AED BATTERY IS DYING FAST AND NOT HOLDING A CHARGE AS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20626035 ↗
• MalfunctionSep 19, 2024Installation-Related Problem; Installation-Related Problem

  CUSTOMER EMAILED IN AND SAID THE PAD CARTRIDGE IS LOOSE AND WILL NOT "CLICK" INTO THE AED SIMILAR TO OTHER UNITS. THE CUSTOMER TRIED THE SAME PAD CARTRIDGE WITH ANOTHER AED AND IT WAS ABLE TO CLICK IN. CUSTOMER CONFIRMED THERE NO WIRES BLOCKING THE PAD CARTRIDGE FROM CLICKING IN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20263226 ↗
• MalfunctionAug 27, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  THE END USER IN CHARGE OF MANAGING ALL AEDS FOR US MARSHALLS SERVICE DISCOVERED THIS AED WAS NOT POWERIN GON AFTER CHARGING FOR 24 HOURS. THERE WAS NO RESPONSE FROM THE AED WHEN THE POWER BUTTON WAS PRESSED, WHEN PROMPTED TO DO A STATUS CHECK AND WHEN THE PAD CARTRIDGE WAS REMOVED. ADDITIONALLY, THERE WERE NO BUTTONS OR LIGHTS FLASHING AT ANY TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20082289 ↗
• DeathAug 27, 2024Product Quality Problem; Product Quality Problem

  BELOW IS AN EMAIL THAT WAS FORWARDED FROM (B)(6). (B)(6), OFC. (B)(6) REPORTED AN ISSUE WITH HIS AVIVE AED ON A RECENT CALL. HE PLACED THE PADS ON THE PATIENT'S CHEST AND THE AED SAID PATIENT DETECTED, AS IT IS SUPPOSED TO. HOWEVER, A COUPLE SECONDS LATER, IT SAID, "PATIENT NOT DETECTED" AND KEPT GIVING INSTRUCTIONS ABOUT PAD PLACEMENT. THE AED NEVER ENDED UP ANALYZING THE PATIENT OR DELIVERING A SHOCK. I REVIEWED HIS BODY CAM FOOTAGE AND THE ONLY THING I NOTICED WAS THAT THE PADS SEEMED SLIGHTLY CLOSER THAN USUAL ON THE PATIENT'S CHEST. DO YOU MIND RUNNING THIS ISSUE PAST YOUR CONTACT AT AVIVE AND SEE IF HE HAS ANY IDEAS AS TO WHAT CAUSED THE ERROR? I CAN SEND OVER A SCREENSHOT OF THE BODY CAM FOOTAGE TO SHOW WHAT I MEAN ABOUT PAD PLACEMENT (AS LONG AS THAT WOULD NOT VIOLATE ANY OF OUR DISCLOSURE POLICIES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20081408 ↗
• MalfunctionJun 25, 2024Key or Button Unresponsive/not Working; Key or Button Unresponsive/not Working

  USER ADAM PENN DISCOVERED THE ALLEGED MALFUNCTION WHEN HE WAS DEMONSTRATING DURING A TRAINING SESSION ON (B)(6). WHEN HE PRESSED THE WHITE AED POWER BUTTON AS WELL AS PULLED RED TAB - THERE WAS NO REACTION FROM THE THE AED. HE CHARGED THE AED OVERNIGHT - AND WAS STILL EXPERIENCING THE SAME NON RESPONSE FROM THE AED. OVER THE PHONE - I HAD ADAM PLUG THE AED IN AND PROMPT A STATUS CHECK - THERE WAS NO REACTION FROM THE AED. THE LIGHT WAS NOT DISPLAYING FLASHING OR COLOR OF ANY KIND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610820 ↗
• DeathMay 15, 2024Failure to Sense; Failure to Sense

  THE CUSTOMER CONTACTED AVIVE TO REPORT WHILE USING THE DEVICE ON A PATIENT, THE DEVICE WAS UNABLE TO DETECT THE PATIENT AFTER ELECTRODE PADS WERE PLACED ON THE PATIENT. THE CUSTOMER PROVIDED THE FOLLOWNG DETAILS DURING A FOLLOW UP WITH THE CUSTOMER: THE PATIENT WAS HIT BY A CAR AND WAS UNRESPONSIVE AT THE SCENE. ONCE POLICE ARRIVED, THE DEVICE WAS PLACED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19323410 ↗