Bard Denali Intravascular Filters Recalled for Missing Contraindications
Bard Peripheral Vascular Inc is recalling 1,183 Denali intravascular filters because the instructions for use are missing critical contraindications regarding sepsis and nickel-titanium allergies.
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, but the hazard is a documentation error (missing contraindications) rather than a physical defect or reported injury, aligning with the rubric for minor labeling errors.
Plain-English summary
Bard Peripheral Vascular Inc is recalling 1,183 units of Denali intravascular filters, specifically the Denali Filter-Jugular/Subclavian (DL950J) and Denali Filter-Femoral Delivery (DL950F) models. The recall was initiated because the Instructions for Use (IFU) for these devices are missing specific contraindications. The omitted information warns against using the filters in patients with uncontrolled sepsis and in patients with known hypersensitivity to nickel-titanium alloys.
The affected units were distributed to California only. The recall involves specific lot numbers for both product codes: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, and GFYI2699. This is classified as an FDA Class II recall.
Healthcare providers and facilities that have received these devices should stop using them and contact Bard Peripheral Vascular Inc for further instructions. Patients who have had these filters implanted should consult their healthcare provider to discuss the missing safety information and determine if any follow-up is necessary.
The recalled product
- Product
- Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
- Manufacturer
- Bard Peripheral Vascular Inc
- Affected units
- 1,183
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 (9)
- Product Code: DL950J Lot Number: GFYA3093
- GFYC3745
- GFYD2734
- GFYF3878
- GFYF3879
- GFYG3877
- GFYG3880
- GFYI2699 Product Code: DL950F Lot Number: GFYA3093
- GFYI2699
Distribution
Distributed in 1 state:
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