Medtronic Perfusion Systems 2025-03-19 Health critical FDA
Health · FDA · Recall #FDA-Z-1306-2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA,… Recall
Issued March 19, 2025 · Medtronic Perfusion Systems
In March 2025, Medtronic Perfusion Systems recalled the Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA,…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
What you should do
- 1 Stop using Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Perfusion Systems to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Medtronic Perfusion Systems
- Category
- Health
- Recall date
- March 19, 2025
- Units affected
- Not reported
- Sold at
- Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria
- Recall number
- FDA-Z-1306-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Perfusion Systems has 11 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.