INSPIRE 7 MRecalls & 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 08033178113182), received between May 10, 2024 and May 10, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (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.
Reports received per month
Most reported problems
Device problems
- Unexpected Therapeutic Results1
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 10, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results
SORIN GROUP ITALY HAS RECEIVED A REPORT OF LIGHT GRADUAL INCREASE IN TRANS-MEMBRANE PRESSURE ACROSS THE INSPIRE AND DECREASED CO2 REMOVAL. MEDICAL TEAM ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19284348 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.