INSPIRE 6F PH.I.S.I.O.Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08033178112376), received between Aug 3, 2018 and Feb 20, 2026 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Unexpected Therapeutic Results” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Unexpected Therapeutic Results

  SORIN GROUP ITALIA RECEIVED A REPORT OF A POOR GAS EXCHANGE PERFORMANCE RELATED TO TWO UNITS OF INSPIRE 6F OXYGENATOR. THERE WAS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401203 ↗
• MalfunctionJan 23, 2026Restricted Flow rate

  SORIN GROUP ITALIA RECEIVED A REPORT THAT, AT THE BEGINNING OF THE PROCEDURE, THE RESERVOIR OF AN INSPIRE 6F OXYGENATOR WAS BLOCKED AND IT WAS DECIDED TO CHANGE THE WHOLE CARDIOPLEGIA CIRCUIT. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162695 ↗
• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALY RECEIVED A REPORT THAT AN INSPIRE 6F OXYGENATOR HAD A SIGNIFICANT LEAKAGE FROM THE ARTERIAL LINE OUTLET DURING PROCEDURE. THE ARTERIAL LINE WAS ADJUSTED, BUT SINCE THE LEAKAGE CONTINUED, MEDICAL TEAM ELECTED TO REMOVE THE PATIENT FROM THE PUMP AND REPLACE THE OXYGENATOR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994647 ↗
• MalfunctionMay 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AT THE TIME OF STARTING THE VALVE REPLACEMENT SURGERY, A LEAK IN THE LUER CONNECTION OF THE ARTERIAL LINE OF THE INSPIRE OXYGENATOR WAS OBSERVED. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE WAS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974700 ↗
• MalfunctionJan 8, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102481 ↗
• InjuryApr 9, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SORIN GROUP ITALIA RECEIVED A REPOR OF AN INSPIRE OXYGENATOR FAILURE DURING A PROCEDURE, THE FIO2 WAS 95% AND PO2 SHOWS ~20%. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071303 ↗
• 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 17442871 ↗
• MalfunctionJun 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALIA RECEIVED A REPORT THAT, AFTER ENTERING INTO BYPASS, A BLOOD LEAK WAS OBSERVED FORM THE TEMPERATURE PROBE HOLDER OF THE INSPIRE 6F OXYGENATOR. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077048 ↗
• MalfunctionOct 26, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING SET UP OF THE HEART LUNG MACHINE, THE PERFUSIONIST NOTICED A PIECE OF FOREIGN MATTER IN THE INSPIRE 6F OXYGENATOR ARTERIAL OUTLET. THE OXYGENATOR WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672528 ↗
• MalfunctionSep 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A MITRAL VALVE REPLACEMENT SURGERY, WHILE ON PUMP, BLOOD LEAK FROM THE PURGE LINE OF THE INSPIRE 6F OXYGENATOR WAS OBSERVED. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15359897 ↗
• MalfunctionAug 5, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT OF ARTERIAL BLOOD DESATURATION HALF AN HOUR AFTER THE BEGINNING OF THE CEC USING AN INSPIRE 6F OXYGENATOR. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15173416 ↗
• MalfunctionApr 15, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A PROCEDURE USING AN INSPIRE 6F OXYGENATOR, THE OXYGEN VALUES IN THE PATIENT BLOOD WERE LOW. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117000 ↗
• MalfunctionMar 21, 2019Particulates; Particulates

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING DEVICE SET-UP, A BLACK FOREIGN PARTICLE WAS IDENTIFIED BY THE OUTLET SIDE OF INSPIRE 6F INTEGRATED ARTERIAL FILTER. THE ISSUE WAS IDENTIFIED PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8440408 ↗
• MalfunctionAug 3, 2018Fluid/Blood Leak; Fluid/Blood Leak

  SORIN (B)(4) RECEIVED A REPORT OF A BLOOD LEAK FROM THE LOWER PORTION OF AN INSPIRE 6F HOLLOW FIBER OXYGENATOR DURING A PROCEDURE. ACCORDING TO THE CUSTOMER, THE TOTAL BLOOD LOSS WAS OF 1000 ML AND THE PATIENT WAS HEMO-TRANSFUSED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7746125 ↗