FDA · Medical device recall

Stainless Steel Greenfield Vena Cava Filter with 12 Fr… and 1 more product

Dec. 23, 2005

Date posted by the FDA: Dec. 23, 2005
Status: Terminated
Filed by: Boston Scientific Scimed
Reason: 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.
Distribution pattern: 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, TN, TX, VA and WI

2 products in this recall

Stainless Steel Greenfield Vena Cava Filter with 12 Fr…

Product: Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Stainless Steel Greeenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4.0 mm jugular or femoral introducer catheter.
Codes and lots: Lot numbers: 7132606, 7132607, 7132608, 7133116, 7136847, 7136848, 7142615, 7142616 and 7147508
Recall started: Aug. 5, 2005
Device type: Filter, Intravascular, Cardiovascular
Root cause (FDA): Other
What the company told customers: 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
Recall number: Z-0299-06

Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System…

Product: Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.
Codes and lots: Lot numbers: 7129578 and 7124116
Recall started: Aug. 5, 2005
Device type: Filter, Intravascular, Cardiovascular
Root cause (FDA): Other
What the company told customers: 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
Recall number: Z-0300-06

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-0299-06, Z-0300-06. The agency record governs; check it and the company before acting.

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