Novalung System XLung kitRecalls & reported problems

Summary

The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 04057224001494), received between Oct 8, 2024 and Sep 25, 2026 — classified as 6 deaths, 2 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (59 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 150 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Noise, Audible

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895663 ↗
• MalfunctionSep 21, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845851 ↗
• InjurySep 18, 2026Fluid/Blood Leak

  A user facility reported a hairline crack in the oxygenator and a slight blood leak that was observed in the two days after the start of extracorporeal membrane oxygenation support utilizing the XLung Kit 230. The kit was replaced resulting in a blood loss of approximately 500 ml to 600 ml. The user administered one unit of packed red blood cells. There was no indication of significant consequence due to blood loss. The complaint sample was available for product evaluation.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50816981 ↗
• MalfunctionSep 15, 2026Calibration Problem

  A user facility reported issues with zeroing the P1 pressure sensing port during calibration with the console startup procedure. There was no patient involvement. The complaint sample was available for product investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771215 ↗
• MalfunctionSep 15, 2026Noise, Audible

  A user facility reported that the circuit was extremely noisy during support. Console information included 38350043, S/N (b)(6) and the pump drive information included 28350048, S/N (b)(6). The speed of the console was set at 5,800 RPM. The kit information included lot GSXL0304. Due to the noise from the pump, and as the patient was able to be weaned from support, the circuit was removed and discarded onsite. There was no indication of patient serious injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770819 ↗
• MalfunctionSep 15, 2026Insufficient Device Problem Information

  A user facility reported a kit failure involving lot HSXB2306 that required exchange on (b)(6) 2026. 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 50770604 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733481 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733221 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  A user facility reported an underperforming oxygenator during extracorporeal membrane oxygenation (ECMO) support that required exchange in less than 8 hours, with a second oxygenator having the same reported issue in less than 12 hours. Upon internal review, the user facility stated that 10 of 16 oxygenators required change out in under one week due to failure. Three of these kits have been accounted for, however, this is to capture the remaining 7 kits included in the customer complaint. Data is still being collected from the customer for review. This case reflects an event where a patient on veno-venous ECMO support experienced suboptimal oxygenation with a post-oxygenator arterial oxygen of 118 mmHg on (b)(6) 2026 requiring product exchange. There was no indication of patient serious injury. The complaint sample was not available for product investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733169 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733022 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  A user facility reported an underperforming oxygenator during extracorporeal membrane oxygenation (ECMO) support that required exchange in less than 8 hours, with a second oxygenator having the same reported issue in less than 12 hours. Upon internal review, the user facility stated that 10 of 16 oxygenators required change out in under one week due to failure. Three of these kits have been accounted for, however, this is to capture the remaining 7 kits included in the customer complaint. Data is still being collected from the customer for review. This case reflects an event where a patient on veno-venous ECMO support experienced hemolysis requiring product exchange. The complaint sample was not available for product investigation.

  Patient problems: Hemolysis

  MAUDE report 50732812 ↗
• MalfunctionSep 11, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50732409 ↗
• DeathSep 8, 2026Insufficient Device Problem Information

  A user facility reported that in early (b)(6) 2026, extracorporeal membrane oxygenation (ECMO) support was initiated for a a patient in pulmonary failure using the first ECMO kit. During support, the patient's condition deteriorated, and while increasing the pump speed above 7,100 RPMs, an abnormal grinding-like noise was observed from the pump head. As the patient's body weight was not large, the pump speed was adjusted to below 7,100 RPMs and support was continued. The first ECMO kit was used for approximately 29 days and then discarded. Around (b)(6) 2026, the ECMO circuit was replaced with a second ECMO kit, and ECMO therapy was continued. When the pump speed was increased to 7,100 RPMs for support, the same abnormal grinding-like noise from the pump head recurred, similar to what had been observed with the first ECMO kit. Consequently, the pump speed was maintained below 7,100 RPMs, and support was continued. On (b)(6) 2026, ECMO support was terminated following the patient's death. Upon follow-up, it was reported that the patient did not experience a serious injury prior to their expiration. The complaint sample was not available for product investigation.

  Patient problems: Cardiac Arrest

  MAUDE report 50668679 ↗
• MalfunctionAug 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  A user facility reported that a patient was placed on extracorporeal membrane oxygenation (ECMO) support due to a severe pulmonary infection. The post-membrane partial pressure of oxygen was approximately 54 mmHg immediately after ECMO initiation, and rose to around 78 mmHg half an hour after commencing support. Considering the unsatisfactory oxygenation performance, the hospital decided to replace the oxygenator resulting in a blood loss of approximately 500 ml. After oxygenator replacement, the post-membrane partial pressure of oxygen increased to 400 mmHg. The batch number of the replacement oxygenator is also GSXE0513. There was no indication of patient serious injury. The complaint sample was not available for product investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472072 ↗
• MalfunctionAug 25, 2026Crack; Fluid/Blood Leak; Material Integrity Problem

  A user facility reported that the vent connection tubing on the venous side ruptured and caused blood leakage. The physician observed the leak 10 minutes following extracorporeal membrane oxygenation (ECMO) support start. The patient's cannulas were clamped with hemostats and the kit was exchanged. There was no indication of patient serious injury. The complaint sample was discarded and unavailable for product investigation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435324 ↗
• MalfunctionAug 17, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50274306 ↗
• MalfunctionAug 7, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50177602 ↗
• MalfunctionJul 27, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50034614 ↗
• MalfunctionJun 25, 2026Obstruction of Flow

  A USER FACILITY SUSPECTED THAT THERE WAS AN OBSTRUCTION AT THE RECIRCULATION PORT DURING EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT. THE RED SIDE BRANCH TUBING WAS FOUND BLOCKED AT THE START OF SUPPORT. THE KIT WAS EXCHANGED. THE PATIENT EXPERIENCED A BLOOD LOSS OF APPROXIMATELY 50 ML AS A RESULT OF THIS EVENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25619698 ↗
• MalfunctionJun 23, 2026Leak/Splash; Mechanical Problem

  A USER FACILITY REPORTED THAT ON THE MORNING OF (B)(6) 2026, A SIGNIFICANT PUDDLE WAS OBSERVED AT THE BASE OF THE MACHINE, AND THE XLUNG KIT TRAY WAS FILLED WITH FLUID. THE EXACT SOURCE OF THE LEAK COULD NOT BE IDENTIFIED; HOWEVER, UPON OPENING THE TRAY, ONE OF THE TUBES CONNECTED TO THE 3/8" FITTING APPEARED TO BE INSUFFICIENTLY INSERTED. IT SHOULD BE NOTED THAT AS THE CIRCUIT WAS FULL OF AIR THE PUMP HEAD WAS DAMAGED DURING OPERATION. THE CIRCUIT THEREFORE HAD TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592888 ↗
• DeathJun 23, 2026Infusion or Flow Problem; Air/Gas in Device

  A user facility reported that the patient circuit was deaired during the day without any issues in preparation for a possible emergency. A patient was transferred to the cardiology department while cardiopulmonary resuscitation (CPR) was being performed. The perfusionist was not available to connect the patient as she was occupied in the operating room with a surgical procedure. The machine was brought down with the pump running in order to keep the circuit under pressure. At the time of connecting the patient, who was still receiving CPR, the circuit was full of air, the pump head was making significant noise and was unable to deliver an adequate flow. The perfusionist arrived but was unable to initiate extracorporeal membrane oxygenation support. As the facility was unable to connect the patient, who was cannulated and still receiving CPR, the decision was made to stop resuscitation, and the patient was declared deceased. The pump head appeared to be damaged, likely because it was de-primed. The complaint sample was received for product evaluation.

  Patient problems: Cardiac Arrest

  MAUDE report 25592786 ↗
• MalfunctionJun 12, 2026Leak/Splash; Mechanical Problem

  A USER FACILITY REPORTED THAT DURING THE ASSEMBLY AND PRIMING OF THE SUPPORT DEVICE, THE PRIMING SOLUTION LEAKED THROUGH THE PORTS FOR THE THERMAL UNIT. THE OXYGENATOR MEMBRANE WAS DAMAGED, SO THE CIRCUIT WAS THEREFORE UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484357 ↗
• DeathJun 11, 2026Insufficient Device Problem Information

  A USER FACILITY REPORTED A LOUD NOISE HEARD DURING SUPPORT COMING FROM THE PUMP HEAD. A NURSE NOTIFIED THE CLINICAL SPECIALIST OF THE NOVALUNG MAKING A LOUD NOISE. THE NURSE RECORDED THE EVENT. THE PATIENT WAS ON SUPPORT FOR APPROXIMATELY 5 DAYS WHILE NO COMPLICATIONS WERE ENCOUNTERED, LDH LEVELS WERE WITHIN NORMAL RANGE AND CONSISTENT THROUGHOUT SUPPORT. THE PATIENT WAS SIGNIFICANTLY ILL WHILE EXHIBITING MULTI-ORGAN FAILURE PRIOR TO INITIATION OF EXTRACORPOREAL MEMBRANE OXYGENATION SUPPORT AS A LAST EFFORT TO TRY AND TURN THEIR CONDITION AROUND. THE PATIENT ULTIMATELY SUCCUMBED TO THEIR ILLNESS SECONDARY TO A SIGNIFICANTLY ISCHEMIC BOWEL. SUPPORT WAS WITHDRAWN WHEN EFFORTS BECAME FUTILE. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: Cardiac Arrest

  MAUDE report 25468952 ↗
• MalfunctionJun 2, 2026Leak/Splash; Mechanical Problem

  A USER FACILITY REPORTED A LEAKAGE OCCURRED FROM THE VENTING PORT DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT SAMPLE WAS DISCARDED ONSITE AND UNAVAILABLE FOR PRODUCT EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25359134 ↗
• MalfunctionMay 28, 2026Leak/Splash; Mechanical Problem

  A USER FACILITY DISCOVERED A CRACKED STOPCOCK ON PRE-MEMBRANE PIGTAIL OF THE XLUNG KIT (USA) DURING PRIMING OF THE STERILE CIRCUIT. THERE WAS A SIGNIFICANT LEAK AT THE POST-OXYGENATOR PIGTAIL THAT CAME FROM THE PROXIMAL LUER-LOCK OF THE THREE-WAY STOPCOCK. PICTURES WERE TAKEN AND THE CIRCUIT WAS SEQUESTERED FOR RETURN TO FRESENIUS. THE PICTURES WERE NOT PROVIDED AS IT WAS DETERMINED THEY DID NOT EFFECTIVELY SHOW THE BREAKAGE. A NEW KIT WAS THEN PRIMED WITHOUT INCIDENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25314558 ↗

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