Recall Z-0908-2014— Medtronic Cardiovascular Surgery-the Heart Valve Division
Class II · Terminated
Class II FDA medical device recall by Medtronic Cardiovascular Surgery-the Heart Valve Division, initiated 2014-01-09, terminated 2014-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.. Reason: 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..
- Recalling firm
- Medtronic Cardiovascular Surgery-the Heart Valve Division
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-01-09
- Terminated
- 2014-05-30
- Firm location
- Santa Ana, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.