Denali Filter-Jugular/Subclavian Delivery System Product Code:… — Class II medical device recall Z-1068-2016
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-1068-2016 |
|---|---|
| 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 | 2,904 |
| Reason classes | packaging |
| Lot numbers | DL900J, DL950J, GFZJ0450, GFZJ0452, GFZJ0454, GFZJ0455, GFZJ0456, GFZJ0459, GFZJ0460, GFZJ1176, GFZJ1177, GFZK0303, GFZK0304, GFZK0305, GFZK0306, GFZK0307, GFZK0308, GFZK0309, GFZK0310, GFZK0311, GFZK0312, GFZK0313, GFZK0314, GFZK0315, GFZK0316, GFZK0317, GFZK0318, GFZK0319, GFZK0340, GFZK0341, GFZK0342, GFZK0343, GFZK0344, GFZK0345, GFZK0346, GFZK0347, GFZK0348, GFZK0349, GFZK0350, GFZK0358 and 18 more |
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.
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-1068-2016. 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.