Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic B

FDA device recall Z-0908-2014 · posted 2014-02-03 · Terminated

Recall details

Recalling firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

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.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

LWR

Quantity affected

8276 units

Distribution

Worldwide Distribution - USA (nationwide)

Date initiated

2014-01-09

Date posted

2014-02-03

Date terminated

2014-05-30

Location

Santa Ana, CA