medical Class II Updated 2020-07-29

Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.1 CX Needle Cryoablati

Recalled Product

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.

Hazard / Issue

The needle surface deteriorated due to unexpected electrolysis during procedure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: FPRPR3603, GTIN: 7290104831010, Batch: A1564, A1521, A6723, A6908, A6929, A7015, T0025, T0056, T0137, T0138, T0269, U0041
View official government recall

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