Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-3257-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

ACCOLADE Pacemaker

Product Classification:

Class II

Date Initiated: September 10, 2018

Date Posted: October 3, 2018

Recall Number: Z-3257-2018

Event ID: 81001

Reason for Recall:

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.

Status: Terminated

Product Quantity:

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

Voluntary or Mandated:

Voluntary: Firm initiated