Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Us

FDA device recall Z-0300-06 · posted 2005-12-23 · Terminated

Recall details

Recalling firm

Boston Scientific Scimed

Reason for recall

Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.

Action taken

Urgent Recall Notice dated 08/04/05 was Federal Express''d to customers for delivery on 08/05/05. This notice informs customers of the issue and identifies affected product. Customers are asked to immediately discontinue use of and segregate these recalled lots. Steps for Voluntary Recall and Tracking/Verification Form were sent to the Risk Manager only. The Tracking/Verification Form is to be completed by the Risk Manager even if there are no affected lots to return. To return affected product, the customer must call Boston Scientific Corporation (BSC) to obtain a Returned Goods Authorization (RGA) number. Returned Goods are to be packaged and sent to BSC with the Tracking/Verification Form and using the enclosed red/white field action return shipping label to: Boston Scientific Marina Bay, 500 Commander Shea Blvd., Quincy, MA 02171

Root cause

Other

Status

Terminated

Product code

DTK

Distribution

OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC

Date initiated

2005-08-05

Date posted

2005-12-23

Date terminated

2006-11-09

Location

Maple Grove, MN

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