Medtronic DLP Aortic Root Cannula (Medtronic) – Potential Sterility Breach (2024)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Brand
Medtronic Perfusion Systems
Lot Codes / Batch Numbers
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Products Sold
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Medtronic Perfusion Systems is recalling Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surg due to There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Recommended Action
Per FDA guidance
Medtronic Cardiac Surgery issued an URGENT: MEDICAL DEVICE RECALL to its consignees on 10/03/2024 via USPS first class mail. The notice explained the problem with the device, potential risk, and requested the affected product be quarantined pending return. The notice is to be shared with all individuals with each facility as appropriate, and the notice distributed to all facilities to which the affected devices was shipped. Contact the local Medtronic Field Representative for questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, MI, NJ, NY, OH, TN, WI
Page updated: Jan 10, 2026