Reported May 22, 2024 · Ongoing
Medtronic Aortic Root Cannulae and Cardioplegia Needles
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
Medtronic Aortic Root Cannulae and Cardioplegia Needles
3 of 3 products
| Model / number | Product as published |
|---|---|
24009 | DLP¿ 9 Ga (11 Fr) Aortic Root Cannula |
11316 | DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length |
11014L | M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-Guard" |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 00673978178646Model Number 24009, , Lot Numbers: 2023040211, 2023040854, 2023041224 20613994495420Model Number 24009, , Lot Numbers: 2023031043, 2023031563, 2023040211, 2023040480, 2023040854, 2023040855, 2023041224, 202305C108, 202305C109, 202306C196 20613994676140Model Number 11316, , Lot Numbers: 2023040437 20613994495499Model Number 11014L, , Lot Numbers: 2023040807, 2023040808, 202305C076, 202306C138 - Amount recalled
- 2622 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Why it was recalled
Potential for unsealed sterile packing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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