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Denali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in the pre...

FDA Device Recall #Z-1069-2016 — Class II — February 9, 2016

Recall Summary

Recall Number Z-1069-2016
Classification Class II — Moderate risk
Date Initiated February 9, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Bard Peripheral Vascular Inc
Location Tempe, AZ
Product Type Devices
Quantity 3572

Product Description

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.

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.

Distribution Pattern

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 of Hong Kong, Malaysia, Canada, Chile.

Lot / Code Information

Product # Lot # 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 DL900F GFZK0295 DL900F GFZK0299 DL900F GFZK0298 DL900F GFZK0300 DL900F GFZK0301 DL900F GFZK0302 DL900F GFZK0351 DL900F GFZK0352 DL900F GFZK0356 DL900F GFZK0355 DL900F GFZK0357 DL900F GFZK0337 DL900F GFZK0354 DL900F GFZK0338 DL900F GFZK0364 DL900F GFZK0339 DL950F GFZK2368 DL900F GFZK3526 DL900F GFZK0367 DL900F GFZK3527 DL900F GFZK3524 DL900F GFZK3525 DL900F GFZK0328 DL900F GFZK0330 DL900F GFZK0331 DL900F GFZK0332 DL900F GFZK0333 DL900F GFZK0334 DL900F GFZK3523 DL900F GFZK0336 DL900F GFZK0335 DL900F GFZK3528 DL900F GFZK3529 DL900F GFZK3530 DL900F GFZK3538 DL900F GFZK3543 DL950F GFZK2369

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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