Class 2 Device Recall Boston Scientific Profile SingleUse Pediatric Snare

• Date Initiated by Firm: May 16, 2012
• Date Posted: June 21, 2012
• Recall Status: Terminated on February 28, 2013
• Recall Number: Z-1851-2012
• Recall Event ID: 61935
• 510(K)Number: K941750
• Product Classification: Snare, flexible - Product Code FDI
• Product: Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The single-use Profile Polypectomy Snare consists of a flexible wire cable loop which can be extended and retracted from the snare's flexible outer sheath using a three-ring handle. When passed through an endoscope and activated, the snare delivers a monopolar electrical current to cut and cauterize tissue with the loop
• Code Information: Lot Numbers: 14951482, 14951484, 15068143
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Same; 508-683-8000
• Manufacturer Reason for Recall: Difficulty in extending snare loop from the catheter
• FDA Determined Cause: Process control
• Action: Boston Scientific issued an Urgent Medical Device Recall Action letter via Federal Express Priority mail on May 16, 2012. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Scan and fax to 508-683-5578. For questions regarding this recall call 508-683-8000.
• Quantity in Commerce: 1970 units
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada, Australia, Austria, Belgium, France, GB, Germany, Italy, Netherlands, Qatar, Spain, Sweden, and Switzerland
• 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 = FDI