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Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Search FDA. Food and Drug Administration. For Government For Press. Adverse Events. CFR Title Radiation-Emitting Products. X-Ray Assembler.
Medsun Reports. New Search. Date Initiated by Firm May 20, The diameter of the vessel at the site of filter loop placement should be between 2. Boston Scientific has determined that the Directions for Use DFU , which accompanies each packaged device, may be missing.
If the product does not include a DFU and the user is unable to find a copy, the user will have to seek another product box containing the DFU.
This may. The letter addressed to Risk Mangers, described the issue and product. A Reply Verification Tracking Form was requested to be completed and returned. Contact Boston Scientific Corporation at for assistance. TN, TX. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated.
Learn more about medical device recalls.
Class 2 Device Recall FilterWire EZ" Embolic Protection System
Study record managers: refer to the Data Element Definitions if submitting registration or results information. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Embolic Protection: The FilterWire EZ Embolic Protection System
FilterWire EZ™ Embolic Protection System