Medical device recalls Moderate risk

Boston Scientific Corporation recalls MOMENTUM X4 CRT-D, Model G138, Sterile.

Recall date
October 4, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0080-2018
FDA classification
Class II
Brand / firm
Boston Scientific Corporation
Sold / distributed
The devices were distributed to medical facilities located in MN and OH. There was no foreign/government/military distribution.

Why it was recalled

The devices have an incorrect firmware configuration.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

MOMENTUM X4 CRT-D, Model G138, Sterile.

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