Novalung System Novalung consoleRecalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04057224902043), received between Apr 30, 2021 and Sep 21, 2026 — classified as 7 deaths, 7 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (25 reports).

2 other recalls cover devices cleared under the same FDA submission (K191407); they may or may not involve this specific model.

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 25 most recent of 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848011 ↗
• MalfunctionSep 15, 2026Insufficient Device Problem Information

  A user facility reported a kit failure involving lot GSXK1302 that required exchange. There was no indication of patient serious injury. Per the clinical support team, the complaint sample was available for product evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770263 ↗
• MalfunctionSep 15, 2026Insufficient Device Problem Information

  A user facility contacted the field medical team to report an underperforming oxygenator that required exchange in less than 24 hours. The circuit was changed and the user once again reached out to medical team to report that the new circuit oxygenator had also failed within 24 hours requiring an additional circuit exchange. Data is still being collected from the user for review. There was no indication of patient serious injury. The complaint sample was not available for product evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770092 ↗
• DeathAug 27, 2026Insufficient Device Problem Information

  A user facility reported a noise that occurred during support for 28 days for a patient on extracorporeal membrane oxygenation support due to pulmonary failure. A grinding-like noise was observed when the speed was increased above 7100 RPM, making it impossible to increase the RPM further. The noise was normal at speeds of 7000 RPM or below. The first kit was initially used at 6600 RPM. As the patient¿s condition deteriorated, attempts were made to increase the rotational speed to 7500 RPM; however, this was not possible due to the abnormal noise. After the kit was replaced, the second kit reportedly produced the same abnormal noise whenever the speed was increased above 7100 RPM from the beginning of use. The user requested a determination of whether this noise is normal or abnormal, and an analysis of the cause of the noise. There was no indication of patient serious injury. The patient expired on (b)(6) 2026 due to an unreported cause. The complaint sample was not available for product investigation.

  Patient problems: Cardiac Arrest

  MAUDE report 50471639 ↗
• MalfunctionJul 10, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25777677 ↗
• MalfunctionMay 4, 2026Electrical /Electronic Property Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT A #00A ALARM OCCURRED AFTER PRIMING THE SYSTEM. BEFORE THE USER ATTEMPTED TO CONNECT THE XLUNG KIT 230 CIRCUIT TO THE PATIENT, THE USER WAS UNABLE TO RESOLVE THE ALARM. THE USER EXCHANGED THE PUMP DRIVE WHICH RESOLVED THE ALARM AND THE PATIENT WAS ABLE TO CONTINUE SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE PUMP DRIVE COMPONENT OF THE CONSOLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067004 ↗
• DeathApr 23, 2026Crack; Material Integrity Problem

  A USER FACILITY REPORTED THAT A PATIENT CAME TO THE CARDIAC CATHETERIZATION LAB FOR A VENTRICULAR TACHYCARDIA AND VENTRICULAR ECTOPIC ARREST FOR INITIATION OF EXTRACORPOREAL CARDIOPULMONARY RESUSCITATION. THE NOVALUNG DEVICE WAS PREPPED TO HAND UP THE PATIENT CIRCUIT INTO THE STERILE FIELD TO START SUPPORT. WHEN HANDED UP TO THE STERILE FIELD, THE P2 PRESSURE CABLE BROKE AND WAS NOT DETECTED ON THE CONSOLE SCREEN. AN ATTEMPT WAS MADE TO PULL THE CORD AND SWITCH TO ANOTHER CABLE; HOWEVER, THE CABLE WAS STUCK IN THE DEVICE. WITHIN A FEW MINUTES OF ECMO SUPPORT THE P3 PRESSURE CABLE ALSO WAS NOT READING A PRESSURE, AND IT WAS FOUND TO BE IN THE XLUNG KIT, BUT NOT ABLE TO READ A PRESSURE. THIS CABLE ALSO REMAINED IN THE DEVICE. ECMO SUPPORT WAS NOT STOPPED DUE TO THE URGENCY OF SUPPORT AT THAT TIME. THE PATIENT WAS HOOKED UP TO BLOOD PRESSURE AND EKG MONITORS TO ENSURE BEST CARE PRACTICES WERE FOLLOWED. ALSO, THE NOVALUNG CONSOLE WAS READING A TOTAL FLOW TO PATIENT WITH RPMS. THE FACILITY¿S BEST PRACTICE IS TO INITIATE ECMO WITH FIO2 OF 50%. THERE WAS NO COLOR CHANGE THAT WAS NOTED ON ARTERIAL LIMB OF CIRCUIT UNTIL THE OXYGEN LEVEL WAS INCREASED TO MAXIMUM SUPPORT OF 100% OXYGEN. UPON

  Patient problems: Cardiac Arrest

  MAUDE report 24965509 ↗
• MalfunctionApr 21, 2026Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT THE FACILITY WAS ATTEMPTING TO PLACE A PATIENT ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. EVERYTHING WAS FINE FOR ABOUT 20 MINUTES UNTIL THEY RECEIVED AN #211 ALARM FROM THE CONSOLE INVOLVING THE FLOW SENSOR. THE FLOW PROBE APPEARED TO BE CLEAN AND CONNECTED APPROPRIATELY. ADDITIONALLY, THEY RECEIVED A SERIES OF AIR ALARMS WITH NO VISIBLE AIR IN THE CIRCUIT AND NO OBVIOUS SOURCE OF AIR. THEY RECEIVED ANOTHER #211 ALARM AND DECIDED TO SWITCH OUT THE FLOW PROBE. THIS DID NOT SOLVE THE ISSUE AND THEY CONTINUED TO GET AIR ALARMS AND AN ADDITIONAL #211 ALARM. THEY FINALLY DECIDED TO SWITCH OUT THE SENSOR BOX WHICH SOLVED THE ISSUE. THERE WAS NO PATIENT SERIOUS INJURY AS A RESULT. IT WAS UNKNOWN IF THE SENSOR BOX OF THE CONSOLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938187 ↗
• MalfunctionApr 10, 2026Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT AT 13:47 (LOCAL TIME), #00A TECHNICAL FAULT OCCURRED DURING TREATMENT. THE DRIVE PUMP WOULD NOT WORK AND THE NURSE COULD NOT RESET THIS ALARM. THE USER DECIDED TO UTILIZE THE BACKUP DRIVE PUMP FOR CONTINUED SUPPORT. THE USER FACILITY HAS REPORTED THIS RECORD TO THEIR LOCAL NMPA. A TECHNICAL SERVICES REPRESENTATIVE INSPECTED THE DEVICE, TESTED THE CABLING AND OBSERVED ACTUAL FLOW OF THE PUMP DRIVE. THERE WAS NO FAULT IN THE DEVICE FOUND. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24843613 ↗
• MalfunctionMar 26, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT THE P3 SENSOR STARTED READING ABNORMAL PRESSURE READINGS THAT WENT INTO NEGATIVE NUMBERS. THE USER SWITCHED CABLES WITH NO RESOLUTION. THE USER THEN MONITORED PRESSURES USING AN EXTERNAL PRESSURE SENSOR. THE CLINICAL SPECIALIST PERFORMED TROUBLESHOOTING ONSITE WITHIN THEIR SCOPE AND MADE THE DECISION TO APPLY EXTERNAL PRESSURE MONITORING. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698391 ↗
• MalfunctionMar 11, 2026Electrical /Electronic Property Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT APPROXIMATELY 30 TO 45 MINUTES AFTER INITIATION OF SUPPORT, A TEMPORARY MALFUNCTION OF THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SYSTEM OCCURRED. THE EVENT WAS CHARACTERIZED BY A BRIEF SHUTDOWN OF THE CONSOLE DISPLAY AND A SHORT INTERRUPTION OF BLOOD FLOW. FOLLOWING SPONTANEOUS RECOVERY OF THE CONSOLE, AN ALARM INDICATING LOSS OF COMMUNICATION BETWEEN THE SENSOR BOX AND THE CONSOLE WAS DISPLAYED. IMMEDIATE CLINICAL ACTIONS WERE TAKEN, INCLUDING CLAMPING OF THE CANNULAS AND RESTORATION OF BLOOD FLOW. THE SYSTEM RESUMED NORMAL OPERATION AFTER A SHORT INTERRUPTION AND CONTINUED TO FUNCTION WITHOUT RECURRENCE FOR THE REMAINDER OF THE ECMO SUPPORT. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24574362 ↗
• MalfunctionMar 11, 2026Infusion or Flow Problem; No Flow; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT A PATIENT WHO HAD BEEN RECEIVING SUPPORT ON ANOTHER DEVICE WAS CONNECTED TO THE NOVALUNG CONSOLE ON 19/FEB/2026 BETWEEN 1300 AND 1400 (LOCAL TIME), WHICH WAS ALREADY PRIMED. THE USER REPORTED THAT THE MAIN PUMP DID NOT OPERATE, AND NO FLOW VALUE WAS DISPLAYED ON THE CONSOLE. DUE TO THE MAIN PUMP ISSUE, AN ATTEMPT WAS MADE TO CONTINUE SUPPORT BY CONNECTING THE AUXILIARY PUMP AND BATTERY PACK. THE AUXILIARY PUMP ALSO FAILED TO OPERATE, AND SUPPORT COULD NOT BE CONTINUED. THE USER REQUESTED FURTHER VERIFICATION TO DETERMINE WHETHER THE ISSUE WAS CAUSED BY A DEVICE MALFUNCTION OR BY USER OPERATION. THERE WAS NO PATIENT SERIOUS INJURY RESULTING. THE DEVICE AND MACHINE DATA LOG FILES WERE INVESTIGATED ONSITE AT THE USER FACILITY BY TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567803 ↗
• MalfunctionFeb 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT THE P3 INTEGRATED SENSOR WAS NOT WORKING ON THE XLUNG KIT (USA) CIRCUIT. THE SENSOR DID NOT LIGHT UP GREEN ON THE CONSOLE DURING PRIMING AND READ NO PRESSURE DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE ECMO SPECIALIST HAD NO TIME TO CHANGE ANYTHING AS CANNULATION OCCURRED WITHIN 7 MINUTES. THE USER ADDED AN EXTERNAL PRESSURE SENSOR TO P3 AND THE CIRCUIT WAS STILL IN USE ON THE PATIENT. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468750 ↗
• MalfunctionFeb 16, 2026Display or Visual Feedback Problem; Output Problem; Insufficient Device Problem Information; No Visual Prompts/Feedback

  A USER FACILITY REPORTED THAT THE NOVALUNG FLOW SENSING PROBE'S BUBBLE DETECTION FUNCTION IS TOO SENSITIVE AND CAUSING FALSE POSITIVE DEVICE ALARMS DURING EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT. THE USER STATED THAT NOVALUNG FLOW PROBE BUBBLE DETECTION FUNCTION CAUSED ALARM UPON INITIATION OF ECMO WITH NO EVIDENCE OF BUBBLES IN THE CIRCUIT. THE CLINICIAN TURNED BUBBLE DETECTION OFF TO CIRCUMVENT THE ALARM. BUBBLE DETECTION FUNCTION WAS TURNED BACK ON LATER DURING ECMO SUPPORT; HOWEVER, IT CONTINUED TO ALARM DURING THE NIGHT AND WAS AGAIN TURNED OFF. THE CLINICIAN REPLACED THE SUSPECT FLOW PROBE WITH A BACKUP FLOW PROBE WHICH RESOLVED THE ALARM ISSUE. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT INVESTIGATION AS THE FACILITY WANTED TO RETAIN THE PRODUCT AS A BACKUP FLOW SENSOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343285 ↗
• MalfunctionFeb 12, 2026Electrical /Electronic Property Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT FOLLOWING APPROXIMATELY 10 MINUTES AFTER PRIMING THE SYSTEM, THE CONSOLE SHOWED ERROR '206/208'. THE FLOW SENSOR WAS REPOSITIONED BUT DID NOT SOLVE THE ISSUE. THE ERROR MESSAGE WAS REPEATEDLY DISPLAYED UNTIL THE CONSOLE AND KIT WERE EXCHANGED DUE TO THERAPEUTIC REASONS AND NOT BECAUSE OF THE ERROR MESSAGES. ON (B)(6) 2026, A FIELD TECHNICIAN CHECKED THE SENSOR BOX AND BUILT-IN VOLTAGE REGULATOR. IT WAS FOUND THAT THE SENSOR BOX WAS NOT UPDATED WITH THE FIELD CORRECTION AS THE DEVICE WAS TOO OLD. THE CONSOLE WAS FIXED ON SITE. THE REPLACED COMPONENT WAS RETURNED TO XENIOS FOR PRODUCT INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321440 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A CLINICAL SUPPORT SPECIALIST REPORTED THAT THIS 70-YEAR-OLD FEMALE CRITICALLY ILL PATIENT WAS STATUS-POST CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2025 WHO WAS DISCHARGED HOME AND DEVELOPED SEVERE RESPIRATORY FAILURE. EMERGENCY MEDICAL SERVICES TRANSPORTED THE PATIENT TO THE HOSPITAL ON (B)(6) 2026 WHERE THEY TESTED POSITIVE FOR INFLUENZA TYPES A AND B. THE PATIENT WAS CANNULATED FOR VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2026 AND EXPERIENCED SEVERE HYPOTENSION IN THE EARLY MORNING OF (B)(6) 2026 WHILE ON SUPPORT. IT WAS EXPLAINED THAT INITIAL REPORTS OF CARDIAC ARREST WERE FALSE AS THE PATIENT INSTEAD EXPERIENCED SEVERE HYPOTENSION THAT REQUIRED A CHANGE IN ECMO MODALITY FOR CARDIOPULMONARY SUPPORT. AS A RESULT, THE PATIENT WAS TRANSITIONED TO VENO-VENOARTERIAL ECMO SUPPORT ON THE SAME DEVICE AND PATIENT CIRCUIT. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) THAT WAS INITIATED FOR RENAL SUPPORT. THE FILTER OF THE COMPETITOR CRRT DEVICE CLOTTED AND WAS CHANGED OUT THAT MORNING. PLASMA FREE HGB LEVELS WERE CHECKED AND RESULTED AT GREATER

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24320967 ↗
• MalfunctionFeb 5, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED AN ISSUE THAT OCCURRED BETWEEN (B)(6) 2026. DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT, THE RPMS OF THE PUMP WERE REDUCED WITHOUT A CHANGE TO THE CONSOLE. THE USER EXCHANGED THE PATIENT XLUNG KIT 230. THE USER REPORTED A COAGULATION ISSUED ON THE SIDE OF THE PATIENT. THE CUSTOMER WAS CONCERNED ABOUT THE POTENTIAL FOR A TECHNICAL ISSUE. A CLINICAL SUPPORT SPECIALIST WAS ONSITE AND EXPLAINED THE FORMATION OF A CLOT WAS THE PROBABLE CAUSE FOR THE RPM REDUCTION. TECHNICAL SERVICES WERE ONSITE AND CHECKED THE MACHINE TO RULE OUT A TECHNICAL FAILURE. NO TECHNICAL ISSUE WAS FOUND BUT THE FIELD TEAM. THERE WAS NO PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24267274 ↗
• DeathFeb 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  A CLINICAL SUPPORT SPECIALIST REPORTED THAT THIS 70-YEAR-OLD FEMALE CRITICALLY ILL PATIENT WAS STATUS-POST CORONARY ARTERIAL BYPASS GRAFT PROCEDURE ON (B)(6) 2025 WHO WAS DISCHARGED HOME AND DEVELOPED SEVERE RESPIRATORY FAILURE. EMERGENCY MEDICAL SERVICES TRANSPORTED THE PATIENT TO THE HOSPITAL ON (B)(6) 2026 WHERE THEY TESTED POSITIVE FOR INFLUENZA TYPES A AND B. THE PATIENT WAS CANNULATED FOR VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT ON (B)(6) 2026 AND EXPERIENCED SEVERE HYPOTENSION IN THE EARLY MORNING OF (B)(6) 2026 WHILE ON SUPPORT. IT WAS EXPLAINED THAT INITIAL REPORTS OF CARDIAC ARREST WERE FALSE AS THE PATIENT INSTEAD EXPERIENCED SEVERE HYPOTENSION THAT REQUIRED A CHANGE IN ECMO MODALITY FOR CARDIOPULMONARY SUPPORT. AS A RESULT, THE PATIENT WAS TRANSITIONED TO VENO-VENOARTERIAL ECMO SUPPORT ON THE SAME DEVICE AND PATIENT CIRCUIT. THE PATIENT RECEIVED MULTIPLE BLOOD PRODUCTS AND CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WITH A PRISMAX DEVICE (NOT A FRESENIUS/XENIOS PRODUCT) THAT WAS INITIATED FOR RENAL SUPPORT. THE FILTER OF THE COMPETITOR CRRT DEVICE CLOTTED AND WAS CHANGED OUT THAT MORNING. PLASMA FREE HGB LEVELS WERE CHECKED AND RESULTED AT GREATER

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24266913 ↗
• MalfunctionDec 11, 2025Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information; Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED AN 'ERROR 208' ALARM THAT OCCURRED APPROXIMATELY 18 HOURS AFTER TURNING ON THE CONSOLE AND DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WILL NOT BE RETURNED FOR PRODUCT INVESTIGATION AS THE DEVICE WILL BE ADDRESSED ONSITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23777122 ↗
• MalfunctionOct 31, 2025Circuit Failure; Electrical /Electronic Property Problem; Insufficient Device Problem Information; Circuit Failure; Electrical /Electronic Property Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT WHILE NOVALUNG CONSOLE XEN0718 WAS IN CONTINUOUS OPERATION ON A PATIENT FOR THE PAST ONE MONTH, ON (B)(6) 2025 AT 23:30 (LOCAL), THE POWER SUPPLY INDICATION UNEXPECTEDLY DISAPPEARED WHILE THE UNIT WAS CONNECTED TO THE CEILING PENDANT, WHICH IS POWERED VIA A UPS. UPON INSPECTION, IT WAS OBSERVED THAT THE CONSOLE FUSE HAD BLOWN. PRELIMINARY ASSESSMENT INDICATES A PROBABLE FAILURE OF THE SMPS MODULE. THERE WAS NO INDICATION OF SERIOUS PATIENT INJURY. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439829 ↗
• MalfunctionSep 26, 2025Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information; Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THE FOLLOWING ALARMS FROM XENIOS CONSOLE SN XEN0720 UPON STARTING OPERATION AND BEFORE PATIENT APPLICATION: #10E- PUMP DRIVE IN EMERGENCY MODE, #211- TECHNICAL FAILURE, FLOW MEASUREMENT, #009- TECH. THE FACILITY WAS INSTRUCTED TO RESTART THE DEVICE WHICH RESOLVED THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT. THE CONSOLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154023 ↗
• MalfunctionAug 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED THAT ON (B)(6) 2025 AT APPROXIMATELY 7:15 PM (LOCAL), THE XENIOS CONSOLE (S/N (B)(6)), WHICH HAD BEEN ON STANDBY AND PRIMED SINCE (B)(6) 2025 AT 2800 RPM AND 2.0 L/MIN FLOW, UNEXPECTEDLY SWITCHED TO EMERGENCY MODE AND TWO CRITICAL ALARMS WERE TRIGGERED: # 403 - TECHNICAL FAILURE: OPERATOR PANEL AND #10E - PUMP DRIVE IN EMERGENCY MODE. THIS WAS ACCOMPANIED BY CONTINUOUS AUDIBLE WARNING. UPON INSPECTION, THE TOUCH PANEL WAS RESPONSIVE, BUT THE ROTARY KNOB AND SWITCH KEYS WERE NONFUNCTIONAL. AFTER REMOVING AND INSERTING THE CONSOLE´S BATTERIES, THE SYSTEM RESTARTED AND FUNCTIONED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

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

  MAUDE report 22838530 ↗
• MalfunctionAug 15, 2025Display or Visual Feedback Problem; Output Problem; Insufficient Device Problem Information; No Visual Prompts/Feedback; Display or Visual Feedback Problem; Output Problem; Insufficient Device Problem Information; No Visual Prompts/Feedback

  A USER FACILITY REPORTED THAT FOR SEVERAL MONTHS NOW, PERFUSIONISTS AT HENRI MONDOR HOSPITAL IN CRÉTEIL HAVE BEEN REPORTING ABOUT A BACKFLOW DETECTION PROBLEMS ON THE NOVALUNG CONSOLE, SERIAL (B)(6). THIS INCIDENT CAUSES THE PUMP TO ACCELERATE TO 10,000 RPM TO COMPENSATE FOR A FALSE BACKFLOW DETECTED ON THE CONSOLE. THE COUNTRY COMPLAINT ADMINISTRATOR RETRIEVED THE MACHINE LOG FILES CONFIRMING THE PROBLEM. UPON FOLLOW-UP, IT WAS REPORTED THIS EVENT OCCURRED ONE TO TWO TIMES DURING SUPPORT BUT WAS NOT A SYSTEMATIC ISSUE. ASSOCIATED CONSOLE ALARMS INCLUDED #114 (BACKFLOW DETECTED - ZERO FLOW ACTIVATED) AND #221 (BLOOD FLOW TOO LOW). AN EXCHANGE OF THE FLOW SENSOR ALLEVIATED THE ISSUE. IT WAS CONFIRMED THAT THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813973 ↗
• MalfunctionAug 11, 2025Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information; Device Alarm System; Protective Measures Problem; Insufficient Device Problem Information

  A USER FACILITY REPORTED AN ERROR 208 MESSAGE ON THE NOVALUNG CONSOLE DURING PRIMING FOR EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS RECEIVED FOR PRODUCT INVESTIGATION.

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

  MAUDE report 22769762 ↗
• MalfunctionJul 22, 2025Circuit Failure; Electrical /Electronic Property Problem; Loss of Power; Electrical Power Problem; Circuit Failure; Electrical /Electronic Property Problem; Loss of Power; Electrical Power Problem

  A USER FACILITY REPORTED THAT THE NOVALUNG CONSOLE WAS IN USE ON A PATIENT WHEN THE AC POWER SUPPLY INDICATOR UNEXPECTEDLY DISAPPEARED FROM THE SCREEN, AND THE SYSTEM AUTOMATICALLY SWITCHED TO BATTERY MODE. UPON INSPECTION, IT WAS FOUND THAT THE INTERNAL FUSES HAD BLOWN. REPLACEMENT FUSES WERE INSTALLED; HOWEVER, THEY BLEW IMMEDIATELY UPON POWERING ON THE DEVICE. THE ISSUE WAS REPORTED TO THE XENIOS SERVICE TEAM FOR FURTHER INVESTIGATION AND THEY SUGGESTED TO RETURN THE CONSOLE TO XENIOS. THERE WAS NO RESULTING PATIENT SERIOUS INJURY. THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PRODUCT INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22564072 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191407. One submission often covers many models, so check the product and lot details in each record.

• Z-1822-2024 · Apr 8, 2024 · Open, Classified
  Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporea
• Z-0562-2022 · Dec 7, 2021 · Open, Classified
  Novalung Sensor Box (F30000163) a component of Novalung Console (F30000162)- Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extrac