Medtronic Hancock II Mitral Bioprosthesis Recalled for Incorrect Size Labeling
Medtronic is recalling 15 Hancock II T510 Mitral 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 situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding size, which is a significant quality issue but does not involve a structural defect or reported injuries in the source text.
Plain-English summary
Medtronic Inc is recalling 15 units of the Hancock II T510 Bioprosthesis, Mitral, REF T505U227. These surgical heart valves are used for the replacement of malfunctioning native or prosthetic aortic and/or mitral valves. The recall is due to a labeling error where the devices were marked 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 serial numbers for the recalled units are B167637, B192698, B217347, B217329, and B217330.
Healthcare providers and facilities should check their inventory for these specific serial numbers and stop using the affected devices. Patients who have already received these implants should contact their healthcare provider for guidance on whether further evaluation is necessary.
The recalled product
- Product
- Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Manufacturer
- Medtronic Inc
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 5
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 (5)
- GTIN: 00643169000261 Serial Numbers: B167637
- B192698
- B217347
- B217329
- B217330
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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