INSPIRE 7FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033178113359), received between May 2, 2024 and Aug 7, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Increase in Pressure” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2025Increase in Pressure; Increase in Pressure

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22742621 ↗
• MalfunctionMay 2, 2024Increase in Pressure; Increase in Pressure

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURINA A PROCEDURE, INCREASED TRANSMEMBRANE PRESSURE WAS OBSERVED. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. FOLLOWING THE MEMBRANE REPLACEMENT, PRE MEMBRANE PRESSURE REMAINED BETWEEN 250 TO 310 MMHG AT C.I. OF 2,3. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228059 ↗