Medtronic Recalls Valiant Navion Thoracic Stent Grafts Due to Structural Defects
Medtronic is recalling 33,430 Valiant Navion Thoracic Stent Graft Systems worldwide due to endoleaks, stent fractures, and ring enlargement.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, despite the absence of reported injuries in the source text.
Plain-English summary
Medtronic Vascular, Inc. is recalling 33,430 units of the Valiant Navion Thoracic Stent Graft System. These devices are used for endovascular repair of lesions in the descending thoracic aorta. The recall covers specific model numbers and serial numbers distributed globally, including the United States and numerous international markets.
The recall was initiated due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. These structural issues can compromise the integrity of the stent graft. The source text does not report any specific illnesses, injuries, or deaths associated with these defects.
Healthcare providers and patients should contact Medtronic Vascular, Inc. for instructions on how to manage the affected devices. The recall is classified as FDA Class I, indicating a reasonable probability that the use of the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesions in the descending thoracic aorta (DTA).
- Manufacturer
- Medtronic Vascular, Inc.
- Affected units
- 33,430
Distribution
Distributed nationwide across the United States.
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