FDAFDA · Food and drugs·Recall number Z-0908-2014
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Published February 12, 2014 · Recall initiated: January 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Cardiovascular Surgery-the Heart Valve Division
- Distributor
- Worldwide Distribution - USA (nationwide)
- Lot
- Model 7305. Lot/Serial Numbers: The 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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