medical Class II Updated 2018-10-31

Boston Scientific Corporation recalls Boston Scientific Maestro 4000 Cardiac Ablation System, Firm

Recalled Product

Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,

Hazard / Issue

Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.

Issued by

FDA

Affected States: PA, IL, NY, CA, SC, AR, SD, AZ, KY, FL, TX, MA, MI, OH, LA, VA, NC, WA, DE, IN, TN, NJ, CT, AL, ME, GA, NH, MN, MD, DC, OK, HI, WI, CO, MO, IA, NE, OR, ID, UT, RI, KS, NV, MS, WV
Lot/Code Info: All Maestro 4000 Generators used with the optional foot switch.
View official government recall

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