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.
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation has recalled 39 Galil Medical 2.1 CX Cryoablation Needles distributed nationwide across all U.S. states and Canada. These prescription-only needles are designed for cryoablative procedures but were recalled because the needle surface deteriorated due to unexpected electrolysis that occurred during use.
The recall affects devices with specific lot/batch codes including UPN FPRPR3604 and GTIN 7290104831027, with multiple batch numbers listed (A1564, A1521, A6723, A6908, A6929, A6931, A7015, A7083, T0025, T0056, T0137, T0138, T0156, T0166, T0269, U0041, U0042, and others). The recall notice does not specify a remedy or required action 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: 39 devices Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.