INSPIRE 8F PH.I.S.I.O.Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08033178112383), received between Aug 5, 2016 and Jul 31, 2026 — classified as 1 death, 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Increase in Pressure” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Fluid/Blood Leak

  Sorin Group Italia received a report of a leakage from an Inspire 8F oxygenator. The event occurred after 1 hour and 30 minutes of blood circulation. Reportedly, during procedure patient experienced elevated lactate levels and hypoxemia. Consequently, blood transfusion was conducted, which has been considered an additional medical intervention to preclude a serious injury.

  Patient problems: Hypoxia

  MAUDE report 50099526 ↗
• InjuryDec 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23886901 ↗
• MalfunctionJan 15, 2025Increase in Pressure; Increase in Pressure

  SORIN GROUP ITALIA HAS RECEIVED A REPORT OF INCREASED TRANS-MEMBRANE PRESSURE ACROSS INSPIRE OXYGENATOR DURING A PROCEDURE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. PATIENT CONSEQUENCES WERE NOT DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21156548 ↗
• MalfunctionDec 19, 2024Increase in Pressure; Increase in Pressure

  SEE INITIAL REPORT.

  Patient problems: Brain Injury

  MAUDE report 20976290 ↗
• MalfunctionAug 2, 2023Increase in Pressure; Unexpected Therapeutic Results; Increase in Pressure; Unexpected Therapeutic Results

  SORIN GROUP ITALIA RECEIVED A REPORT THAT HIGH TRANSMEMBRANE PRESSURE OCCURRED DURING A PROCEDURE. MEDICAL TEAM ELECTED TO ADMINISTER MAG 2GM AND ALBUMIN 12.5GM. SURGERY WAS COMPLETED WITHOUT ANY NEED FOR UNIT CHANGE-OUT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442777 ↗
• MalfunctionNov 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15812842 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Increase in Pressure; Fluid/Blood Leak; Increase in Pressure

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE TRANSMEMBRANE PRESSURE ACROSS AN INSPIRE 8F OXYGENATOR INCREASED CAUSING LEAKAGE. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THE PROCEDURE WAS PROLONGED. PATIENT IMPACT IS BLOOD LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14306936 ↗
• DeathAug 11, 2020Increase in Pressure; Increase in Pressure

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, 30 MINUTES AFTER THE BEGIN OF THE PROCEDURE, THE VALUES OF THE TRANSMEMBRANE PRESSURE OF THE INSPIRE OXYGENATOR WERE HIGH. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. AFTER THE CHANGE OUT, THE VALUES OF THE TRANSMEMBRANE PRESSURE BACK TO NORMAL. LIVANOVA HAS BEEN INFORMED THE PATIENT HAS DIED ON THE SAME DATE (B)(6) 2020). THE MEDICAL TEAM DOES NOT BELIEVE THERE IS ANY CORRELATION BETWEEN THE EVENT AND PATIENT DEMISE.

  Patient problems: Death

  MAUDE report 10391318 ↗
• MalfunctionDec 23, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SEE INITIAL REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 9510704 ↗
• MalfunctionDec 23, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING SET-UP, A FOREIGN MATERIAL WAS SEEN BY THE CARDIOPLEGIA ARTERIAL OUTLET OF THE INSPIRE 8F. THE DEVICE WAS CHANGED-OUT. THE ISSUE OCCURRED PRIOR TO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9510692 ↗
• MalfunctionJul 18, 2019Fluid/Blood Leak; Fluid/Blood Leak

  LIVANOVA RECEIVED A REPORT THAT, DURING A CARDIOPULMONARY BYPASS, LEAKAGE FROM THE TEMPERATURE PROBE HOLDER WAS OBSERVED. THE EVENT OCCURRED AT THE END OF THE PROCEDURE, WHEN THE PERFUSIONIST REMOVED THE TEMPERATURE PROBE FROM THE HOUSING, IT WAS NOT NECESSARY TO REPLACE THE OXYGENATING SYSTEM. THERE WAS NO LEAKAGE DURING SURGERY. THE MEDICAL TEAM ELECTED TO ADMINISTER BROAD-SPECTRUM ANTIBIOTIC TO THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8802337 ↗
• MalfunctionMar 15, 2019Pressure Problem; Pressure Problem

  SEE INITIAL REPORT.

  Patient problems: Neurological Deficit/Dysfunction

  MAUDE report 8424330 ↗
• MalfunctionFeb 13, 2019Pressure Problem; Pressure Problem

  SORIN GROUP (B)(6) HAS RECEIVED A REPORT THAT, 10 MINUTES AFTER THE BEGINNING OF A PROCEDURE, THE DELTA TRANS-MEMBRANE PRESSURE OF THE INSPIRE 8F OXYGENATOR ROSE TO 300 MMHG. THE MEDICAL TEAM ELECTED TO CHANGE-OUT RESERVOIR, OXYGENATOR AND EQUIPMENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2019, SORIN GROUP (B)(6) HAS BEEN INFORMED THE CHANGE-OUT TOOK 5 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8335073 ↗
• MalfunctionJul 13, 2018Increase in Pressure; Increase in Pressure

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TRANSMEMBRANE PRESSURE OF THE INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR INCREASED DURING A PROCEDURE. THE USER WAS ABLE TO DECREASE THE PRESSURE SLIGHTLY BY INCREASING THE BLOOD TEMPERATURE FROM 34°C TO 37°C. AFTER THE PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED HAEMATURIA AND STRONGER THAN NORMAL SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. DURING FOLLOW-UP INFORMATION SORIN HAS BEEN INFORMED THAT THERE IS NO REPORT OF PATIENT INJURY.

  Patient problems: Hematuria; Inflammation

  MAUDE report 7684656 ↗
• MalfunctionApr 24, 2018Increase in Pressure; Increase in Pressure

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE PRE-MEMBRANE PRESSURE OF AN INSPIRE 8F HOLLOW FIBER OXYGENATOR AND THE TENSION OF THE TUBING BETWEEN THE PUMP OUTLET AND THE OXYGENATOR INLET INCREASED DURING A PROCEDURE. THE REPORT ALSO INDICATED THAT THE PUMP FLOW COULD NOT BE SET HIGHER THAN 2 LPM. THE MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR, WHICH TOOK ROUGHLY 200 SECONDS. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7454954 ↗
• Aug 5, 2016Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT, DURING EXTRACORPOREAL CIRCULATION, A BLOOD LEAK WAS DETECTED FROM THE TEMPERATURE PROBE OF THE INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS CARDIOTOMY RESERVOIR. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5850213 ↗