Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling
Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.
What this means for you
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 is a significant risk but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Medtronic Inc is recalling 15 units of the Hancock II T510 Bioprosthesis, Mitral (REF T510C27). 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 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 US states of Tennessee, New York, and New Jersey, as well as in France, Italy, Libya, Poland, and Spain. The specific unit identified has GTIN 00643169594425 and Serial Number B710405. Healthcare providers should verify the size of the valve against the packaging before use.
The recalled product
- Product
- Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Manufacturer
- Medtronic Inc
- 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: 00643169594425 Serial Number: B710405
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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