DLP Aortic Root Cannula with Flow-Guard recallZ-0289-2025 · Medtronic Perfusion Systems · initiated Oct 3, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0289-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 3, 2024
- Posted by the FDA
- Nov 4, 2024
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 420 units
- Product code
- DWF
- FDA submissions
- K790565
- Distribution
- US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
Product description
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Code information (models, lots, serial numbers)
UDI/DI 20613994495451, Lot Numbers: 2023050066, 202307C101, 202401C304
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
Product lines
Other devices under the same FDA submission
6 devices cleared under K790565 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MiAR™ Aortic Root Cannula with Flow-Guard™ 11014LMedtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls2 reports
- MiAR™ Aortic Root Cannula with Flow-Guard™ 11012LMedtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11014Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 11316Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS1 recall0 reports
- DLP® 10014Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
- DLP® 10012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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