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

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08033178112369), received between Jan 31, 2017 and Apr 9, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Mar 13, 2018Class IITerminated

   Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.

   Z-1919-2018 · Root cause: Incorrect or no expiration date · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP ITALY RECEIVED A REPORT RELATED TO A POSSIBLE BLOOD TO WATER LEAK OF AN INSPIRE 8 OXYGENATOR. THE ISSUE OCCURRED TOWARD THE END OF THE PROCEDURE, WHEN IT WAS NOTICED LIGHT PINK/RED TINGE IN THE WATER LINES. MEDICAL TEAM CHOSE TO FINISH THE SURGERY AS IT WAS VERY LIGHT TINGED IN COLOR AND THE CASE WAS ALMOST COMPLETE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19070311 ↗
• MalfunctionMar 22, 2024Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

  SORIN GROUP ITALY RECEIVED A REPORT OF A SUDDEN BLOOD ACTIVATION INSIDE INSPIRE 8 OXYGENATOR DURING BYPASS ON A LONG CASE. MEDICAL TEAM ELECTED TO CHANGE OUT THE AFFECTED UNIT. NO FURTHER DETAILS ABOUT SURGICAL PHASE (BEATING HEART SURGERY OR AORTIC CROSS-CLAMP) AND DURATION OF THE CHANGE OUT OPERATION WERE COMMUNICATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18957694 ↗
• MalfunctionAug 2, 2021Increase in Pressure; Increase in Pressure

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257992 ↗
• MalfunctionAug 11, 2017Low Readings; Device Operational Issue; Low Readings; Device Operational Issue

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT LOW OXYGEN LEVELS WERE FOUND BY THE PERFUSIONIST FOR THE INSPIRE 8 HOLLOW FIBER OXYGENATOR THEN THE BLOOD GAS PARAMETER WAS ANALYZED UPON THE START OF BYPASS. THE PERFUSIONIST DECIDED TO SWITCH TO A NEW MEMBRANE OXYGENATOR TO CONTINUE. THE CHANGE OUT WAS DONE AFTER COOLING DOWN OF THE PATIENT. OXYGEN LEVELS WERE RESTORED AFTER THE CHANGE OUT. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787410 ↗
• MalfunctionFeb 17, 2017Increase in Pressure; Pressure Problem; Increase in Pressure; Pressure Problem

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT HIGH TRANSMEMBRANE PRESSURE WAS OBSERVED FOR THE INSPIRE 8 HOLLOW FIBER OXYGENATOR AT THE BEGINNING OF A PROCEDURE. THE MEDICAL TEAM ELECTED TO CONTINUE THE CASE. DURING THE COOLING PHASE, THE OXYGENATOR TRANSMEMBRANE PRESSURE INCREASED AND THE MEDICAL TEAM ELECTED REPLACE THE DEVICE AT THIS TIME. THE WHOLE PROCEDURE WAS PROLONGED OF 40 MINUTES. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6338721 ↗
• MalfunctionJan 31, 2017Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT TRACES OF BLOOD WERE OBSERVED IN THE WATER OUTLET OF THE INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR ABOUT 50 MINUTES AFTER STARTING BYPASS. THE MEDICAL TEAM OPTED TO CONTINUE THE SURGERY WITHOUT CHANGING THE OXYGENATOR. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6289851 ↗