FDA Device recall Z-3255-2018
ESSENTIO Pacemaker
- FDA Device
- Class II
- terminated
- Published 2018-10-03
On 2018-10-03 the FDA classified a Class II recall of ESSENTIO 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-3255-2018 |
| 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
ESSENTIO 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 | ESSENTIO SR model L100, ESSENTIO DR model L101, ESSENTIO MRI SR model L110, ESSENTIO MRI DR model L111, ESSENTIO EL DR…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 |
|---|
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-3255-2018%22
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