FDA-Device2021-07-14Class II
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Boston Scientific Corporation
Hazard
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.
Sold states
Worldwide distribution.
Affected count
31548 units
Manufactured in
4100 Hamline Ave N Bldg 3, Saint Paul, MN, United States
Products
Essentio pacemaker, Models: a) L100 b) L101 c) L110 d) L111 e) L121 f) L131
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2021Don't want to check this manually?
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