medical Class II Updated 2020-07-29

Boston Scientific Corporation recalls Ablation Galil Technology, IcePearl 2.1 CX 90 Cyroablation N

Recalled Product

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.

Hazard / Issue

The needle surface deteriorated due to unexpected electrolysis during procedure.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UPN: FPRPR3617, GTIN: 07290104831072 , Batch: A0904, A1085, A1177, A1178, A6681, A6682, A6962, A6963, A6977, A7113, U0084
View official government recall

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