Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling
Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. 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: This is an FDA Class II recall involving a labeling error where the device size is misstated. While the device is larger than labeled, the source does not report injuries, illnesses, or deaths, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Medtronic Inc is recalling 15 units of the Mosaic 310 Bioprosthesis, Mitral (REF 310C31). These devices are used for the replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
The recall was initiated because the affected devices were mislabeled with an incorrect size. In all 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 (TN, NY, NJ) and in France, Italy, Libya, Poland, and Spain. The specific unit identified has GTIN 00643169594869 and Serial Number B804937. Healthcare providers should verify the size of the device against the packaging and contact Medtronic for further instructions.
The recalled product
- Product
- Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Manufacturer
- Medtronic Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- 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: 00643169594869 Serial Number: B804937
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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