Bard Denali Filter Delivery System 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 'High' severity criteria for risk-of-harm products without reported injury.
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 due to a defect where the stop cocks on the devices may potentially crack.
The Denali Filter-Jugular/Subclavian Delivery System (Product Codes DL900J/DL950J) is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava. The recall covers 2,904 units distributed nationwide in the United States, including DC and Puerto Rico, as well as in specific countries including Hong Kong, Malaysia, Canada, and Chile.
Consumers and healthcare providers should contact Bard Peripheral Vascular, Inc. for instructions on how to return the affected devices. The specific lot numbers affected are listed in the agency's recall record.
The recalled product
- Product
- Denali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; 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
- Hazard
- Affected units
- 2,904
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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- Severe
- Severe
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