FREEDOM SOLO ART23SGRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896208000382), received between May 19, 2017 and May 19, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMay 19, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  DURING SURGERY ON (B)(6) 2017, IT WAS NOTICED THAT THE COMMISSURE BETWEEN RIGHT AND NON-CORONARY CUSPS WERE NOT AT THE SAME HEIGHT, HOWEVER, ALL COMMISSURES HOWEVER WERE AT SAME DISTANCE FROM EACH OTHER. THE SURGEON DECIDED TO IMPLANT SOLO 23MM VALVE AND AFTER DECLAMPING THE AORTA, A CENTRAL LEAK 2/4 WAS NOTICED ON ECHOCARDIOGRAM. THEREFORE THE VALVE WAS EXPLANTED AND A PERIMOUNT SIZE 21 VALVE WAS IMPLANTED. THE DELAY IN SURGERY WAS ABOUT 60 MINUTES. THE PATIENT IS DOING WELL NOW AND HAS RETURNED HOME.

  Patient problems: Aortic Insufficiency

  MAUDE report 6578114 ↗