Bard Denali Filter Delivery Systems Recalled for Cracking Stop Cocks
Bard Peripheral Vascular is recalling Denali Filter Delivery Systems because stop cocks may crack.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (cracking stop cocks) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Bard Peripheral Vascular, Inc. is recalling the Denali Filter-Jugular/Subclavian Delivery System and the Denali Filter-Femoral Delivery System. The recall is being conducted because the stop cocks on these devices are potentially cracking.
The Denali Filter-Femoral Delivery System is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. The affected product codes are DL900F and DL950F. The recall covers 3,572 units that were distributed nationwide in the United States, including DC and Puerto Rico, as well as in Hong Kong, Malaysia, Canada, and Chile.
Consumers and healthcare providers should contact Bard Peripheral Vascular, Inc. for further instructions regarding the recall and replacement of affected devices.
The recalled product
- Product
- Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava.
- Manufacturer
- Bard Peripheral Vascular Inc
- Category
- Medical Device — Vascular Filter
- Affected units
- 3,572
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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