Class 2 Device Recall Five IceRod" Cryoablation Needles

• Date Initiated by Firm: November 18, 2020
• Create Date: December 22, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0690-2021
• Recall Event ID: 86777
• Product Classification: Unit, cryosurgical, accessories - Product Code GEH
• Product: Five IceRod" i-Thaw" Prostate Cryoablation Kit
• Code Information: UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252
• 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: 178 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.