Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1069-2016 — 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.

U.S. FDA — Device Enforcement · United States · 2016-02-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1069-2016
Date of alert: 2016-02-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bard Peripheral Vascular Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1069-2016 — 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.

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