Z-0289-2025 Class II Ongoing
FDA device recall Z-0289-2025 was initiated by Medtronic Perfusion Systems on Oct 3, 2024 and is designated Class II. Reason for recall: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal The recall status is ongoing. Affected quantity: 420 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 13, 2024
- Initiation Date
- Oct 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 420 units
Product Description
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Reason for Recall
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Distribution Pattern
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Code Information
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0289-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026