Boston Scientific Corporation recalls ESSENTIO Pacemaker
Recalled Product
ESSENTIO Pacemaker
Hazard / Issue
Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
Issued by
FDA
Affected States: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV, WY
Lot/Code Info: ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131
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