medical Class II Updated 2018-10-03

Boston Scientific Corporation recalls ACCOLADE Pacemaker

Recalled Product

ACCOLADE 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: ACCOLADE SR model L300, ACCOLADE DR model L301, ACCOLADE MRI SR model L310, ACCOLADE MRI DR model L311, ACCOLADE EL DR model L321 and ACCOLADE MRI EL DR model L331.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →