Lower riskMedical device recall · FDA · Published October 3, 2024
Medtronic DLP Aortic Root Cannula Recall: Sterility Risk from Misaligned Seal
Medtronic recalls DLP Aortic Root Cannula with Flow-Guard (REF 11012) due to potential sterility breach from misaligned seal in specific lots. Affected units sold for cardiopulmonary bypass surgery.
“Medtronic DLP Aortic Root Cannula Recall: Sterility Risk from Misaligned Seal.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53828-medtronic-dlp-aortic-root-cannula-recall-sterility-risk-from-misaligned. Based on FDA recall #Z-0289-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2025%22&limit=1).
The FDA announced on Oct. 3, 2024, that Medtronic Perfusion Systems is recalling the DLP Aortic Root Cannula with Flow-Guard due to potential sterility breaches. The agency issued recall number Z-0289-2025 for the Class II device.
How to tell if you have it
Brand: Medtronic Perfusion Systems
Product: Medtronic DLP Aortic Root Cannula with Flow-Guard
REF: 11012
UDI/DI: 20613994495451
Lot Numbers: 2023050066, 202307C101, 202401C304
Units affected: 420
Sold in: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
The hazard
According to the FDA, there is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal.
Context
GovInfoNow's records show Medtronic Perfusion Systems has 31 other recalls on record since 2017-06-22. Recent brand recalls include the EOPA Cannula recall on 2026-06-24, the Pediatric Cannula recall on 2026-05-25, and the Octopus 4 Tissue Stabilizer Model 29400 recall on 2026-05-12. Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Affect Sterility (2026-01-07) and Medline Surgical Drapes Recall: Sterility Risk from Calibration Issues (2026-01-07).
How to tell if you have this one
Check for the product name 'DLP Aortic Root Cannula with Flow-Guard', reference number REF 11012, and lot numbers 2023050066, 202307C101, or 202401C304. These units were sold for cardiopulmonary bypass surgery.
Brand
Medtronic Perfusion Systems
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for the lot numbers 2023050066, 202307C101, or 202401C304 on the cannula packaging or label.
Where it went and when
Where it was distributed
Distributed in 7 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Michigan, New Jersey, New York, Ohio, Tennessee, Wisconsin.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The product is safe for use only if it has a lot number not listed in the recall. If your lot number matches the recalled ones, it may have a sterility risk.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0289-2025 (October 3, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0289-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.