INSPIRE 8 DUAL PH.I.S.I.O.Recalls & reported problems
Sorin Group Italia Srl · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033178112406), received between Mar 14, 2017 and Nov 24, 2021 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Pressure 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
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Pressure Problem1
Patient problems
- Air Embolism2
- Death1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 24, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionApr 2, 2019Pressure Problem; Pressure Problem
SORIN GROUP (B)(4) HAS RECEIVED A REPORT OF INCREASED INSPIRE 8 TRANS-MEMBRANE PRESSURE AT THE BEGINNING OF A PROCEDURE. THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. DURING FOLLOW-UP INFORMATION WITH THE CUSTOMER, ON MARCH 04TH 2019, SORIN GROUP (B)(4) HAS BEEN INFORMED THAT LIDOCAINE WAS ADMINISTERED TO THE PATIENT DURING THE PROCEDURE AS A CONSEQUENCE OF THE INCREASED TRANS-MEMBRANE PRESSURE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8473265 ↗DeathMar 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SORIN GROUP (B)(4) RECEIVED A REPORT THAT MASSIVE ARTERIAL AIR EMBOLISM OCCURRED WHILE USING INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR. THE PATIENT HAS EXPIRED.
Patient problems: Air Embolism; Death
MAUDE report 6403391 ↗
Other OXYGENATOR, CARDIOPULMONARY BYPASS devices
- HLS Set BEQ-HLS 7050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls13 deaths90 reports
- Affinity Fusion® BB811Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls90 reports
- HLS Set BEQ-HLS 5050 USAMaquet Cardiopulmonary AG · Oxygenator, Cardiopulmonary Bypass3 recalls4 reports
- NA HLS Set Advanced 5.0, Small Adult, BIOLINE CoatingMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS3 recalls0 reports
- A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. SterileEurosets Srl · Oxygenator, Cardiopulmonary Bypass2 deaths106 reports
- CAPIOX®FX CX*FX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass2 deaths102 reports
- CAPIOX®RX CX*RX25RWTerumo Corporation · Oxygenator, Cardiopulmonary Bypass1 death102 reports
- QUADROX-i HMO 50000-USA #SQUADROX-i Small Adult, no FilterMaquet Cardiopulmonary AG · OXYGENATOR, CARDIOPULMONARY BYPASS2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page