Class 2 Device Recall IceFORCE" Cryoablation Needles

• Date Initiated by Firm: November 18, 2020
• Create Date: December 22, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0658-2021
• Recall Event ID: 86777
• 510(K)Number: K152133
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: IceFORCE" 2.1 CX Cryoablation Needle
• Code Information: UPN: FPRPR3604 UDIs: 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027, 7290104831027 Batch Numbers: U0903, U0785, U0617, U0042, T0166, T0156, A7083, A6931, A6928, A6916, A6734, A1549, A1527, X1483, A1203
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Scimed Pl; Maple Grove MN 55311-1565
• For Additional Information Contact: Nicole Pshon; 763-494-1700
• Manufacturer Reason for Recall: Complaint trend regarding needle shaft gas leaks.
• FDA Determined Cause: Under Investigation by firm
• Action: Customers will be sent a product advisory via overnight mail.
• Quantity in Commerce: 75 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 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