FDA Medical Device Recalls (openFDA)
Bard Peripheral Vascular Inc: Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
- Recall number
- Z-0737-2016
- Recalling firm
- Bard Peripheral Vascular Inc
- Product
- Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
- Status
- Terminated
- Initiated
- 2015-03-13
- Posted
- 2016-02-01
- Terminated
- 2016-02-01
- Reason
- IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
- Root cause
- Labeling Change Control
- Action
- The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada
- Quantity
- 1,183 units
- Distribution
- Distributed to CA only.
- Lot, serial or model codes
- Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699
- 510(k) numbers
- ["K130366"]
- PMA numbers
- not on file
- Product code
- DTK
- Firm FEI
- 2020394
- Firm city
- Tempe
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28