Boston Scientific Corporation: Medical Device Recall in 2018 - (Recall #: Z-3258-2018)

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:

VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)

Product Classification:

Class II

Date Initiated: September 10, 2018

Date Posted: October 3, 2018

Recall Number: Z-3258-2018

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:

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

Voluntary or Mandated:

Voluntary: Firm initiated