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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033178112420), received between Jan 14, 2022 and Dec 6, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Medical Gas Supply Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 6, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING AN EXTRA CORPOREAL CIRCULATION PROCEDURE, AT FIO2 OF 60% AND GAS FLOW AT 2.50 L/MIN, THE PAO2 RESULTED 50.6 MMHG. MEDICAL TEAM INCREASED THE FIO2 TO 100% AND THE PAO2 INCREASED TO 429 MMHG. MEDICAL TEAM DECREASED THE FIO2 BACK TO 60% AND THE PAO2 BECOME 57.9 MMHG. MEDICAL TEAM RE-INCREASED THE FIO2 TO 100% AND THE PAO2 INCREASED TO 427 MMHG. MEDICAL TEAM DECREASED THE FIO2 TO 80% AND PERFORMANCE OF THE INSPIRE OXYGENATOR DECLINED. DURING THE WARMING PHASE, EVEN THOUGH THE FIO2 WAS INCREASED TO 90%, THE PAO2 VALUES WERE POOR. THERE IS NO REPORT OF ANY PATIENT INJURY. ACCORDING TO INFORMATION, THE DAY BEFORE THE EVENT, THE OXYGENATOR HAD BEEN PRIMED AND RECIRCULATED FOR 3 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15922641 ↗
• MalfunctionJan 14, 2022Medical Gas Supply Problem; Medical Gas Supply Problem

  LIVANOVA RECEIVED A REPORT THAT, AN OXYGENATOR REPLACEMENT DUE TO POOR OXYGENATION. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258091 ↗