Bard Flair Endovascular Stent Graft Recalled for Deployment Failures
Bard Peripheral Vascular is recalling 292 units of the FLAIR Endovascular Stent Graft due to potential deployment failures during use.
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 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 II and involves a structural defect (deployment failure) in an implanted medical device, which aligns with the rubric criteria for Severe severity (structural defect/significant injury risk).
Plain-English summary
Bard Peripheral Vascular Inc. is recalling 292 units of the FLAIR Endovascular Stent Graft (Product Codes FAS08070 and FAF08070, Implant Size 8mmx70mm). The recall is being conducted because of the harm associated with failure to deploy or deployment-related issues that could occur during use.
The affected devices are flexible, self-expanding endoprostheses comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. They are available in both flared and straight configurations. The recall covers units distributed nationwide in the US.
The source text does not specify specific actions for consumers or patients, nor does it provide a list of specific lot numbers in the narrative text, though structured data indicates multiple lots are involved. Patients who have had this device implanted should consult their healthcare provider regarding the recall.
The recalled product
- Product
- FLAIR Endovascular Stent Graft, Product Code: FAS08070, FAF08070, Implant Size: 8mmx70mm The FLAIR Endovascular Stent Graft (implant) is a flexible, self-expanding endoprosthesis comprised of expanded polytetrafluoroethylene (ePTFE) encapsulating a Nitinol stent framework. The…
- Manufacturer
- Bard Peripheral Vascular Inc
- Hazard
- Affected units
- 292
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 (1)
- Product Code: FAF08070
Distribution
Distributed nationwide across the United States.
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