W L Gore Recalls 15 Thoracic Stent Grafts Due to Labeling Error
W L Gore & Associates is recalling 15 Conformable Thoracic Stent Grafts distributed in Japan because incorrect labels were placed on the primary and secondary 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, but the source text explicitly states the issue is an incorrect label on packaging and does not report any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
W L Gore & Associates, Inc. is recalling 15 units of the Conformable Thoracic Stent Graft. This medical device is intended for the endovascular repair of lesions of the descending thoracic aorta. The recall is limited to units distributed internationally to the country of Japan.
The recall was initiated because incorrect labels were placed on both the primary and secondary packages of the affected devices. The specific part number for the recalled devices is TGM343420J. The affected serial numbers range from 21225065 to 21225084.
Healthcare providers and patients who have received these specific devices should contact W L Gore & Associates, Inc. for further instructions. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.
- Manufacturer
- W L Gore & Associates, Inc.
- Category
- Medical Device — Vascular Stent
- Hazard
- Affected units
- 15
Distribution
Distribution scope not specified by the agency.
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