Reported Mar 16, 2016 · Terminated

Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the prevention of recurrent…

Bard Peripheral Vascular Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St · Tempe, AZ · 85281-2438

Is this the product you have?

  • Denali Filter-Femoral
  • Delivery System Product CodeDL900F/DL950F; Indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava
Lot codes and dates
  • Product # Lot #

    134 of 134 codes

    • DL900F
    • GFZJ0276
    • DL900F
    • GFZJ0278
    • DL900F
    • GFZJ0277
    • DL900F
    • GFZJ0279
    • DL900F
    • GFZJ0421
    • DL900F
    • GFZJ0425
    • DL900F
    • GFZJ0430
    • DL900F
    • GFZJ0432
    • DL900F
    • GFZJ0429
    • DL950F
    • GFZJ0223
    • DL900F
    • GFZJ0433
    • DL900F
    • GFZJ0434
    • DL950F
    • GFZJ1174
    • DL900F
    • GFZJ0436
    • DL900F
    • GFZJ0435
    • DL900F
    • GFZJ0442
    • DL900F
    • GFZJ0443
    • DL900F
    • GFZK0287
    • DL900F
    • GFZJ0446
    • DL900F
    • GFZK0291
    • DL900F
    • GFZK0288
    • DL900F
    • GFZJ0444
    • DL900F
    • GFZK0290
    • DL900F
    • GFZK0289
    • DL900F
    • GFZK0292
    • DL900F
    • GFZK0294
    • DL900F
    • GFZK0296
    • DL900F
    • GFZK0293
    • DL900F
    • GFZK0294
    • DL900F
    • GFZK0297
Amount recalled
3572

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 13, 2016 · Data as of Sep 19, 5:59 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.