Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling
Medtronic is recalling 15 Hancock II T510 Bioprosthesis 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: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error (incorrect size) rather than a structural defect or contamination, and no injuries or illnesses are reported in the source text.
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 United States (TN, NY, NJ) and in France, Italy, Libya, Poland, and Spain. The specific serial numbers for the affected units are B654768, B694390, B818699, B887929, B896723, B896730, and B914146. The GTIN is 00643169027077. Healthcare providers should verify the size of the valves against the packaging and contact Medtronic for further instructions.
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
- Hazard
- Affected units
- 7
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 (7)
- GTIN: 00643169027077 Serial Numbers: B654768
- B694390
- B818699
- B887929
- B896723
- B896730
- B914146
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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