Ablation Galil Technology, IcePearl 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 48 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, which use extreme cold to destroy tissue. The needles were recalled because their surface deteriorated due to unexpected electrolysis that occurred during procedures.
The affected needles have UPN FPRPR3603, GTIN 7290104831010, and were distributed in batches A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, and U0041. The source does not specify a remedy or recommended 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: 48 devices Lot/code info: UPN: FPRPR3603, GTIN: 7290104831010, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.