Ablation Galil Technology, IceForce 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 is recalling 656 IceForce 2.1 CX 90 Cryoablation Needles due to needle surface deterioration caused by unexpected electrolysis during procedures. The needles, which are prescription-only medical devices intended for cryoablative destruction, were distributed nationwide across all U.S. states and Canada. The affected devices are identified by UPN FPRPR3618, GTIN 07290104831089, and multiple batch codes ranging from X2073 through U0161.
The recall 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: 656 devices Lot/code info: UPN: FPRPR3618 , GTIN: 07290104831089, Batch: X2073, X6812, A0815, A0994, A1044, A1046, A1188, A1189, A1544, A1545, A1774, A1775, A2029, A2030, A6677, A6678, A7032, A7033, A7082, T0134, T0135, T0142, T0143, T0275, T0278, U0160, U0161
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.