Reported Aug 24, 2016 · Terminated
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the…
Medtronic Cardiovascular Surgery-the Heart Valve Division
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 Cardiovascular Surgery-the Heart Valve Division · 1851 E Deere Ave · Santa Ana, CA · 92705-5720
Is this the product you have?
- Medtronic EnVeo R Delivery Catheter System (DCS)
- ModelsENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve
- Lot codes and dates
- all lots
- Amount recalled
- 7,319 units
Where it was sold
Why it was recalled
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
This product could cause temporary or reversible health problems — stop using it.
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