Reported Feb 12, 2014 · Terminated
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic…
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?
- Product NameModel 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses
- Lot codes and dates
- Model 7305
- Lot/Serial NumbersThe catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD. Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants
- Amount recalled
- 8276 units
Where it was sold
- Nationwide
Why it was recalled
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.
This product could cause temporary or reversible health problems — stop using it.
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