Z-3258-2018 Class II Terminated
FDA device recall Z-3258-2018 was initiated by Boston Scientific Corporation on Sep 10, 2018 and is designated Class II. 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. The recall status is terminated (terminated Nov 4, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- Oct 3, 2018
- Initiation Date
- Sep 10, 2018
- Termination Date
- Nov 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
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.
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
Code Information
VALITUDE X4 (CRT-P) model U128
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3258-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026