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U.S. Department of Health and Human Services

Class 2 Device Recall Model 7305 Mosaic Aortic Obturator

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  Class 2 Device Recall Model 7305 Mosaic Aortic Obturator see related information
Date Initiated by Firm January 09, 2014
Date Posted February 03, 2014
Recall Status1 Terminated 3 on May 30, 2014
Recall Number Z-0908-2014
Recall Event ID 67242
Product Classification heart-valve, non-allograft tissue - Product Code LWR
Product Product Name: Model 7305- Mosaic Aortic Obturator

The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
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.
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular Surgery-the Heart Valve Division
1851 E Deere Ave
Santa Ana CA 92705-5720
For Additional Information Contact
949-474-3943
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action Medtronic sent an Customer Notification letter dated January 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. Your Medtronic Field Representative will be contacting you about receiving a new Mosaic Aortic Obturator/Sizer set and sizing chart. If you would prefer to order the new Mosaic Aortic Obturator/Sizer set directly through Medtronic Customer Service, contact them at 1-800-848-9300. Medtronic will notify all applicable regulatory agencies, as required, about this matter. Please share this notification with others in your organization as appropriate. We appreciate your review of this notification and apologize for the inconvenience that it may cause. If you have any questions, please contact your Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890.
Quantity in Commerce 8276 units
Distribution Worldwide Distribution - USA (nationwide)
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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