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Boston Scientific Corporation recalls VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Recalled July 14, 2021 · FDA recall Z-2003-2021 · Boston Scientific
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. · FDA Class II
Units
5920 units
Sold at
Worldwide distribution.
Description
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.
Product
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →