Ablation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation 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 88 units of the IceFORCE 2.1 CX Prostate Cryoablation Kit, which includes Galil Medical's 2.1 CX Cryoablation Needles used in prostate cryoablation procedures. The needles were distributed nationwide across all U.S. states and Canada. The recall was initiated because the needle surface deteriorated due to unexpected electrolysis occurring during the procedure.
The affected devices are identified by UPN FPRPR3607, GTIN 7290104831058, and batches A1194, A1298, A1436, A1569, A1567, A1782, A6754, A6757, A6848, A6849, A6915, T0154, T0163, T0552, and U0083. The source document does not specify what action affected consumers should take in response to 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: 88 devices Lot/code info: UPN:FPRPR3607, GTIN: 7290104831058, Batch: A1194, A1298, A1436, A1569, A1567, A1782, A6754, A6757, A6848, A6849, A6915, T0154, T0163, T0552, U0083
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.