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Recall Observatory FDA recall evidence

Device product

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

Z-0908-2014

January 09, 2014

Class II

Product summary

Firm
Medtronic Cardiovascular Surgery-the Heart Valve Division
Event
Event 67242
Status
Terminated
Classification
Class II
Quantity
8276 units
Official record key
device-enforcement:Z-0908-2014

Official wording

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.

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.

Distribution pattern: Worldwide Distribution - USA (nationwide)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.