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

Products covered by this recall
#Product as published
1ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100
2ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125
3ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
Lot codes and dates

4 of 4 products

Products covered by this recall
Model / numberProduct 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:56 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.