INSPIRE 8MRecalls & reported problems
Sorin Group Italia Srl · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033178112260), received between Sep 13, 2019 and Sep 12, 2024 — classified as 3 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Increase in Pressure2
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2024Increase in Pressure; Increase in Pressure
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20198192 ↗MalfunctionSep 12, 2024Increase in Pressure; Increase in Pressure
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20198159 ↗MalfunctionSep 13, 2019Fluid/Blood Leak; Fluid/Blood Leak
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.