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INSPIRE 7 DUALRecalls & 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 08033178113236), received between May 26, 2022 and May 26, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Increase in Pressure” (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

  • Increase in Pressure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 26, 2022Increase in Pressure; Increase in Pressure

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, AT THE BEGINNING OF A PROCEDURE, TRANSMEMBRANE PRESSURE ACROSS AN INSPIRE 7 OXYGENATOR INCREASED OVER 300 MMHG. THE GAS EXCHANGES PERFORMANCE WERE SATISFYING. THE PROCEDURE WAS CONCLUDED WITHOUT ANY ISSUE. THERE IS NOT REPORT OF ANY PATIENT INJURY. ON (B)(6) 2022, LIVANOVA RECEIVED THE PUMP SHEET OF THE PROCEDURE AND IDENTIFIED THAT 1MG OF MAGNESIUM WAS ADMINISTERED TO PATIENT FOLLOWING TRANSMEMBRANE PRESSURE INCREASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14516609 ↗

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