FDA Medical devices recall ·
Medtronic DLP Aortic Root Cannula with Flow-Guard recall
- Recall number
- Z-0289-2025
- Date
- (initiated October 3, 2024)
- Company / brand
- Medtronic Perfusion Systems
7611 Northland Dr N, Brooklyn Park, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 420 units
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Why was it recalled?
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Distribution
US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
States: Illinois Michigan New Jersey New York Ohio Tennessee Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0289-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.