INSPIRE 6F MRecalls & reported problems
Sorin Group Italia Srl · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033178112277), received between Apr 27, 2018 and May 9, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
Device problems
- Disconnection2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 9, 2018Disconnection; Disconnection
SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE CARDIOPLEGIA CONNECTOR WAS DISCOVERED TO BE DETACHED FROM THE BODY OF THE INSPIRE 6F HOLLOW FIBER OXYGENATOR DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7497680 ↗MalfunctionApr 27, 2018Disconnection; Disconnection
SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE CARDIOPLEGIA CONNECTOR WAS DISCOVERED TO BE DETACHED FROM THE BODY OF THE INSPIRE 6F HOLLOW FIBER OXYGENATOR DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7468155 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.