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Boston Scientific Corporation recalls VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Recalled July 14, 2021 · FDA recall Z-2002-2021 · 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
6377 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
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →