Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a labeling error where the device is larger than indicated, which poses a risk of improper fit during surgery, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc is recalling 15 units of the Mosaic 310 Bioprosthesis, Mitral (REF 310C29). These surgical heart valves are used for the replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
The recall was initiated because the devices were mislabeled with an incorrect size. In all affected cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
The affected devices were distributed worldwide, including in the United States (Tennessee, New York, New Jersey) and in France, Italy, Libya, Poland, and Spain. The specific unit identified has GTIN 00643169594852 and Serial Number B743335. Healthcare providers should verify the size of the implanted or pending valves against the physical device rather than relying solely on the packaging labels.
The recalled product
- Product
- Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Manufacturer
- Medtronic Inc
- Category
- Medical Device — Cardiovascular
- Affected units
- 1
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 (1)
- GTIN: 00643169594852 Serial Number: B743335
Distribution
Part of a larger recall action
This product is one of 5 recalled by Medtronic Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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