Recall Z-0300-06 ยท DTK Filter, Intravascular, Cardiovascular
Boston Scientific Scimed
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 designe
| Date | Dec 23, 2005 (initiated Aug 5, 2005) |
| Status | Terminated |
| 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. |
| Root cause | Other |
| Action | 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 Author |
| 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, TN, TX, VA and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901659 | TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS Boston Scientific Corp, Nov 8, 1990 |