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INSPIRE 7Recalls & 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 08033178113212), received between Apr 24, 2019 and Apr 24, 2019 — classified as 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Pressure Problem1

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.

  • MalfunctionApr 24, 2019Pressure Problem; Pressure Problem

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT DURING A PROCEDURE, TRANSMEMBRANE PRESSURE ROSE. GAS EXCHANGE PERFORMANCES WERE NOT AFFECTED. THE MEDICAL TEAM ELECTED TO ADMINISTER NITROPRUSSIDE AND RINGER ACETATE TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUE: THE TRANSMEMBRANE PRESSURE WAS STABILIZED AND IT DECREASED TO STANDARD VALUES. THERE WAS NO REPORT OF ANY PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8543114 ↗

Other Reservoir, blood, cardiopulmonary bypass devices

All Reservoir, blood, cardiopulmonary bypass devices →

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