Edwards SAPIEN 3 Transcatheter Heart Valve Recalled for Incorrect Size Labeling
Edwards Lifesciences is recalling one SAPIEN 3 Transcatheter Heart Valve because it was packaged with the incorrect valve size relative to the label.
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 and involves a labeling/packaging error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Edwards Lifesciences, LLC is recalling one unit of the SAPIEN 3 Transcatheter Heart Valve (THV), Model 9600TFX, Size 26 mm. The recall is due to a packaging error where the valve was packaged with the incorrect valve size with respect to the label.
The affected unit has the serial number 6005731 and a use-by date of January 24, 2020. The distribution pattern is listed as NJ. The Universal Device Identifier (UDI) is (01)00690103194357(17)200124(21)6005731.
This recall is classified as Class II by the FDA. Healthcare providers and facilities should check their inventory for this specific serial number and contact Edwards Lifesciences for instructions on how to proceed.
The recalled product
- Product
- Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm
- Manufacturer
- Edwards Lifesciences, LLC
- 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 (3)
- Use By: 2020-01-24
- Serial #: 6005731
- UDI #: (01)00690103194357(17)200124(21)6005731
Distribution
Distributed in 1 state:
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