—#142563

Product

Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.

FDA product code: DTK — Filter, Intravascular, Cardiovascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K130366
Affected lot / code info: Product Code: DL950J Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699 Product Code: DL950F Lot Number: GFYA3093, GFYC3745, GFYD2734, GFYF3878, GFYF3879, GFYG3877, GFYG3880, GFYI2699

Why it was recalled

IFU missing contraindications: Patients with uncontrolled sepsis and Patients with known hypersensitivity to nickel-titanium alloys.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

The firm sent out Medical Device Recall customer notification letters on 03/13/15. The notification letter stated that there is no required action on the customer's part. Customers were told that if the device did not meet their needs then the firm will provide a replacement unit. Effective immediately the firm is implementing a change in the ordering code for the device to accurately reflect the approved information with the IFU and corresponding retrieval kit. Any questions the firm states to call Bard Canada: 1-800-268-2862 Western Canada 1-800-387-9473 Ontario 1-800-387-7851 Eastern Canada

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Distributed to CA only.

Timeline

Recall initiated: 2015-03-13
Posted by FDA: 2016-02-01
Terminated: 2016-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142563. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.