medical Class II Updated 2018-10-03

Boston Scientific Corporation recalls PROPONENT Pacemaker

Recalled Product

PROPONENT 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: PROPONENT SR model L200, PROPONENT MRI models L201, L211, and LL231, and PROPONENT EL DR model L221.
View official government recall

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