Ablation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling 79 cryoablation needles used in the IceFORCE 2.1 CX Prostate Kit Visual ICE System for cryoablative procedures. The needles were distributed nationwide across all U.S. states and Canada. The recall was issued because the needle surface deteriorated due to unexpected electrolysis occurring during the procedure.
The affected devices are identified by UPN FPRPR3605, GTIN 7290104831034, and batch numbers A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, and T0153. The recall record does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The needle surface deteriorated due to unexpected electrolysis during procedure.
Reason for recall: The needle surface deteriorated due to unexpected electrolysis during procedure. 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. Quantity: 79 devices Lot/code info: UPN: FPRPR3605, GTIN: 7290104831034, Batch: A1105, A1193, A1291, A1435, A1550, A1565, A1776, A1781, A6758, A6930, A7062, A7061, T0153
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.