Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
Worldwide distribution.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2021