In the agency's Nov 11, 2026 enforcement report · Ongoing
Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog…
Edwards Lifesciences, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Edwards Lifesciences, LLC · 1 Edwards Way · Irvine, CA · 92614-5688
Is this the product you have?
- Generic NameEdwards Commander
- M Delivery System Generic NameEdwards Commander
- M Delivery System Model/Catalog Number9880CM29A
- Software VersionNot applicable
- Product DescriptionProsthesis, mitral valve
- percutaneously delivered ComponentNo
- Lot codes and dates
- Lot CodeModel No.: 9880CM29A
- UDI-DI00690103219777
- Recalled Lot Number(s)
67718561678040146788704367887044
- Amount recalled
- 164
Where it was sold
Why it was recalled
Stop using this product now
Due to a manufacturing issue which may result in cardiovascular balloon rupturing.
Using this product could cause serious injury, illness or death — stop using it now.
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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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