FDA recall Z-2002-2021

Product

VALITUDE CRT-P pacemaker, Models: a) U125 b) U128

Reason for recall

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.

Distribution

Worldwide distribution.

Key facts

Status

Ongoing

Initiation date

2021-06-03

Report date

2021-07-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2002-2021