FDAFDA · Food and drugs·Recall number Z-0289-2025
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Published November 13, 2024 · Recall initiated: October 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
- Lot
- UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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