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

Sorin Group Italia Srl · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033178112413), received between Jan 4, 2018 and Jan 4, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Readings” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Low Readings1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 4, 2018Low Readings; Low Readings

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE VENOUS SATURATION OF THE INSPIRE 6F DUAL HOLLOW FIBER OXYGENATOR DROPPED TO 42% FOR AROUND 6 MINUTES AND THE OXYGENATION DECREASED AFTER STARTING VENTILATION DURING A CORONARY ARTERY BYPASS GRAFT SURGERY. THE OXYGENATOR WAS CHANGED OUT WITHOUT ANY INTERRUPTION OF THE PROCEDURE THANKS TO A SHUNT. FULL FLOW WAS PUSHED UP TO 7 L/MIN TO ACCOMMODATE THE FLOW TO 2 L/MIN IN THE NEW OXYGENATOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7163234 ↗

Other OXYGENATOR, CARDIOPULMONARY BYPASS devices

All OXYGENATOR, CARDIOPULMONARY BYPASS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.