FDA & Regulatory
Recalls, PMA approvals, and adverse events for heart valve devices
2 events
RecallMay 25, 2026
Recall: Presource Custom Sterile Packs containing the Cardiovascular Split Drape II; the custom sterile packCompany: Cardinal Health
The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use.
RecallMay 25, 2026
Recall: Procedure packs:
(1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, ExtractioCompany: Cardinal Health 200, LLC
Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).