Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral… — Class II medical device recall Z-0737-2016
Terminated recall by Bard Peripheral Vascular Inc, reported 2016-02-10, distributed in CA. IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to n
| Recall number | Z-0737-2016 |
|---|---|
| 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 | 2015-03-13 |
| Classified | 2016-02-01 |
| Reported by FDA | 2016-02-10 |
| Terminated | 2016-02-01 |
| Distributed | CA |
| Quantity | 1,183 units |
| Lot numbers | GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 |
Product
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Reason for recall
IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.
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-0737-2016. 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.