Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-3255-2018)

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:

ESSENTIO Pacemaker

Product Classification:

Class II

Date Initiated: September 10, 2018

Date Posted: October 3, 2018

Recall Number: Z-3255-2018

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:

ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR model L121, and ESSENTIO MRI EL DR model L131

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