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Medtronic Perfusion Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery - safety alert
Official notice
13 Nov 2024
Last checked
13 Nov 2024
An official FDA notice concerns Medtronic Perfusion Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery - safety alert. An official FDA notice concerns Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-11-13. Lots: 2023050066. Recall numbers: Z-0289-2025. Check the official notice for the complete list. Published 2024-11-13.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
420
Recall number
Z-0289-2025
Official notice
2024-11-13
The hazard
The hazard
An official FDA notice concerns Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2024-11-13. Lots: 2023050066. Recall numbers: Z-0289-2025. Check the official notice for the complete list.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Affected area 2
Company & contacts
Company & contacts
Brand: Medtronic Perfusion. Contact: Medtronic Perfusion Systems.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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