Class 2 Device Recall Boston Scientific /Micorvasive

• Date Initiated by Firm: July 03, 2003
• Date Posted: July 29, 2003
• Recall Status: Terminated on June 17, 2004
• Recall Number: Z-1061-03
• Recall Event ID: 26713
• 510(K)Number: K935814
• Product Classification: Instrument, Biopsy - Product Code KNW
• Product: ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250
• Code Information: 4104836, 4145036, 4211323, 4290090 ,4370503 4405122, 4445839, 4461241, 4569317, 4666229 4916051, 5022356, 5120746, 5133248, 5251508, 5288530
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Place; Natick MA 01760
• For Additional Information Contact: Robert T. Miragliuolo; 508-652-5186
• Manufacturer Reason for Recall: Sterility of the device may be compromised due to a lack of package integrity
• FDA Determined Cause: Other
• Action: Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.
• Quantity in Commerce: 1,030 units
• Distribution: Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. 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.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KNW