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Recall Observatory FDA recall evidence

Device product

ACCOLADE Pacemaker

Z-3257-2018

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-3257-2018

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: 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.

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.