FDA & Regulatory
Recalls, PMA approvals, and adverse events for heart valve devices
Company: Cardinal Health
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
Company: Cryolife Inc
Additional information obtained from the Outside Tissue Procurement Organization indicated that the donor's attending physician stated that the patient had pneumonia and it possibly might have been a...
Company: Cardinal Health 200, LLC
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).
Company: Edwards Lifesciences, LLC
A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
Company: Abbott Medical
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impact...
Company: LifeNet
Recalling firm distributed a heart valve from donor whose sera was found potentially positive for Hepatitis C.