Z-0908-2014 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2014
- Initiation Date
- January 9, 2014
- Termination Date
- May 30, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8276 units
Product Description
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide)
Code Information
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.