FDA Device recall Z-3258-2018
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) by Boston Scientific, citing 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 bat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3258-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-09-10 |
| Published | 2018-10-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | 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, WI, WV, WY |
Product
VALITUDE X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker)
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.
Identifiers
| code_info | VALITUDE X4 (CRT-P) model U128 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3258-2018%22
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