Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F — Class II medical device recall Z-1069-2016
Terminated recall by Bard Peripheral Vascular Inc, reported 2016-03-16, distributed nationwide. Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter
| Recall number | Z-1069-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2016-02-09 |
| Classified | 2016-03-08 |
| Reported by FDA | 2016-03-16 |
| Terminated | 2016-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CL, HK, MY |
| Quantity | 3,572 |
| Reason classes | packaging |
| Lot numbers | DL900F, DL950F, GFZJ0223, GFZJ0276, GFZJ0277, GFZJ0278, GFZJ0279, GFZJ0421, GFZJ0425, GFZJ0429, GFZJ0430, GFZJ0432, GFZJ0433, GFZJ0434, GFZJ0435, GFZJ0436, GFZJ0442, GFZJ0443, GFZJ0444, GFZJ0446, GFZJ1174, GFZK0287, GFZK0288, GFZK0289, GFZK0290, GFZK0291, GFZK0292, GFZK0293, GFZK0294, GFZK0295, GFZK0296, GFZK0297, GFZK0298, GFZK0299, GFZK0300, GFZK0301, GFZK0302, GFZK0328, GFZK0330, GFZK0331 and 28 more |
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.
Reason for recall
Bard Peripheral Vascular, Inc. is recalling Denali Filter-Jugular/Subclavian Delivery System and Denali Filter-Femoral Delivery System because of the stop cocks potentially cracking.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1069-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.