Boston Scientific Corporation recalls VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacema
Recalled Product
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy 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: VALITUDE X4 (CRT-P) model U128
View official government recall
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