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

Denali Filter-Jugular/Subclavian Delivery System Product Code… — recall Z-1068-2016

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

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1068-2016
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
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution-US (nationwide) including DC and PR, and the states of MN, TX, PA, OH, IL, OR, CA, SC, NC, AK, NY, MD, GA, NJ, AZ, KY, OH, WI, AL, AR, MO, FL, MA, MT, TN, LA, CT, NE, WV, VA, NV, ME, UT, CO, WY, AR, DE, NM, IN, MN, MS, NH, IA, MI, WA, VA, KS, HI, RI, SD, VT, and the countries
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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.

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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.