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Recall Observatory FDA recall evidence

Device product

VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Z-3258-2018

September 10, 2018

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 81001
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-3258-2018

Official wording

Reason: 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.

Code information: VALITUDE X4 (CRT-P) model U128

Distribution pattern: 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, PR, RI, SC, SD, TN, TX, UT, VA, W A, WI, WV, and WY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.