Z-0289-2025Class II

Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery

Name: Z-0289-2025 Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Creator: Medtronic Perfusion Systems
Published: 2024-10-03
License: https://open.fda.gov/license/

Medtronic Perfusion Systems / initiated 2024-10-03 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Perfusion Systems began a recall of Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery on 2024-10-03. FDA classified it as Class II and gives the reason as "There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0289-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-03
Posted: 2024-11-04
Recalling firm: Medtronic Perfusion Systems
Product: Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 420 units
Distribution: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Product codes and lots: UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0289-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0289-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-11-13	2024-11-04

Product code DWF

K790565Class IIAortic Root CannulaDlp, Inc. / cleared 1979-06-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)