medical Class II Updated 2020-07-29

Boston Scientific Corporation recalls Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyro

Recalled Product

Ablation Galil Technology, Three IceFORCE 2.1 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.

Hazard / Issue

The needle surface deteriorated due to unexpected electrolysis during procedure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN:FPRPR3608, GTIN: 7290104831065, Batch: A1170, A1583, A1937, A6710, A6744, A6857, A6900, A6913, A6926, A7014, A7027, A7122, T0055, T0144, T0181, T0211, T0212, T0238, T0270, T0816, T0815
View official government recall

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