Reported May 22, 2024 · Ongoing
Medtronic Intracoronary Shunts
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 Intracoronary Shunts
3 of 3 products
| # | Product as published |
|---|---|
| 1 | ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100 |
| 2 | ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125 |
| 3 | ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200 |
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 20885074257116Model Numbers: 31100, , Lot Numbers: 2023081208 20885074257406Model Numbers: 31125, , lot Numbers: 2023041455, 202306C205 00885074257433Model Numbers: 31200, , Lot Numbers: 2023040542 20885074257437Model Numbers: 31200, , Lot Numbers: 2023040542, 2023041002, 202305C173 - Amount recalled
- 1410 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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