Class 2 Device Recall IcePearl 2.1 CX Ne edle Cryoablation Needle

• Date Initiated by Firm: June 04, 2020
• Create Date: July 21, 2020
• Recall Status: Open, Classified
• Recall Number: Z-2677-2020
• Recall Event ID: 85815
• 510(K)Number: K152133
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: Ablation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription Only; ; Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
• Code Information: UPN: FPRPR3604, GTIN: 7290104831027, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041 A1203, A1549, A6734, A6916, A6928, A6931, A7083, T0156, T0166, U0042
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 300 Boston Scientific Way; Marlborough MA 01752-1291
• For Additional Information Contact: Nicole Pshon; 508-683-4000
• Manufacturer Reason for Recall: The needle surface deteriorated due to unexpected electrolysis during procedure.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Boston Scientific sent a letter dated 06/04/2020 and titled, "Urgent Medical Device Removal - Immediate Action Required" to customers regarding the IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The firm initiated a removal of specific lots/batches of IceFORCE 2.1 CX and IcePearl 2.1 CX Cryoablation Needles. The letter states that further distribution or use of any remaining product affected by the removal should cease immediately. Customers should verify the product lot/batch number to identify whether any product within their inventory is affected. If they have affected product in their inventory customers should respond and follow the instructions on the verification form. Customers must complete the Reply Verification Tracking Form and returned even if you do not have any of the units from the recalled lot/batch and email or fax your Reply Verification Tracking Form(s) immediately to get a Returned Goods Authorization Number (RGA #) before you return any product. Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Package/Ship the Recalled Product. Seal the box, and return to: Boston Scientific Corporation, US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: Replacement product will be provided once affected product has been received by Boston Scientific Distributors should forward the notification to customers. Facilities that have sent products to another hospital within their network, should ensure that the notification is forwarded to them. Customers should contact their local sales representatives; email: BSCFieldActionCenter@bsci.com or can contact Sr. Regulatory Affairs Specialist at 508-683-40 or email: clara.johnson@bsci.com regarding any questions associated with the notification. BSCFieldActionCenter@bsci.com
• Quantity in Commerce: 39 devices
• Distribution: Nationwide Distribution to states of: AL, AR, AZ, CA, CO, CT, DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI WV, and WY and the country of: Canada.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEH and Original Applicant = GALIL MEDICAL LTD