Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, 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 205 Galil Medical 2.1 CX Cryoablation Needles used for cryoablative procedures. The needles were distributed nationwide across all states and Canada. The recall was initiated because the needle surface deteriorated due to unexpected electrolysis during the procedure. The affected devices have UPN FPRPR3617, GTIN 07290104831072, and batch numbers A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, and U0084.
The source record does not specify what action affected consumers should take regarding this recall.
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: 205 devices Lot/code info: UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.