Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients
Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the defect involves a structural issue (high transvalvular gradients) in a critical cardiac device, which aligns with the rubric criteria for 'Severe' (structural vehicle defect or significant injury/property-damage reports, or high-risk medical device defects).
Plain-English summary
Medtronic, Inc. has initiated a recall of the Mosaic Aortic Obturator, Model 7305. This device is used in conjunction with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305. The recall involves 8,276 units that were distributed nationwide in the United States and worldwide.
The recall was initiated because of higher-than-expected transvalvular gradients occurring after the devices were implanted. The scope of the notification includes all Mosaic Obturators/Sizers used with Mosaic Porcine Aortic Bioprosthesis implants, specifically catalog numbers 7305C, 7305UX, and 7305OD.
The source text does not provide specific instructions for consumers or patients on how to proceed or contact the manufacturer. Patients who have had these devices implanted should consult their healthcare providers for guidance.
The recalled product
- Product
- Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
- Category
- Medical Device — Cardiac
- Affected units
- 8,276
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 7305UX
- and 7305OD. Scope of this notification includes all Mosaic Obturators/Sizers
- used with Mosaic Porcine Aortic Bioprosthesis implants.
Distribution
Distributed nationwide across the United States.
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