Medtronic Open Pivot Aortic Valve Graft Box Labeling Error Recall
Medtronic is recalling two Open Pivot Aortic Valve Grafts because the outer box was mislabeled as Aortic while the device was Mitral.
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 a labeling error where the device itself was correctly labeled, fitting the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic ATS Medical, Inc. is recalling two units of the Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm. The recall was initiated after a complaint was received in China indicating that the label on the box for an Open Pivot Heart Valve was labeled as Aortic, but the product was Mitral. The valve itself was correctly labeled as Mitral.
The affected devices are identified by UDI 00643169297913 and Serial Numbers 935603 and 935732. The distribution pattern for these specific units is listed as China. This recall addresses a labeling discrepancy on the packaging rather than a defect in the valve device itself.
Healthcare providers and patients should verify the labeling on the valve device itself, which was correctly identified as Mitral, to ensure the correct product is used. No specific instructions for consumers are provided in the source text beyond the identification of the affected units and the nature of the labeling error.
The recalled product
- Product
- Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
- Manufacturer
- MEDTRONIC ATS MEDICAL, INC.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 2
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 (3)
- UDI 00643169297913
- Serial Numbers: 935603
- 935732
Distribution
Distribution scope not specified by the agency.
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