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Boston Scientific Corporation recalls Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil M
Recalled July 29, 2020 · FDA recall Z-2681-2020 · Boston Scientific
Hazard
The needle surface deteriorated due to unexpected electrolysis during procedure. · FDA Class II
Units
71 devices
Sold at
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.
Description
The needle surface deteriorated due to unexpected electrolysis during procedure.
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.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →