Resolution II Clip

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Company: Boston Scientific Corp., 100 Boston Scientific Way, Marlborough, MA 01752-1234; Ph.: 508-683-5578.
Recall began: August 12, 2011.
Device(s): Resolution II Clip, 155-cm size and 235-cm size, Boxes of 1, 10, and 20 clips consist of a preloaded, radiopaque single-use clip on a flexible delivery system (Recall # Z-3056-2011).
For codes:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=102859.
Quantity: 14,093 boxes of both size clips.
Reason for recall: The firm received reports in which, after clip deployment, the alignment of the clip and delivery system did not allow for the withdrawal of the delivery system away from the clip, resulting in tissue trauma, increased bleeding, and the clip being pulled off tissue as the delivery system was withdrawn.
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