Boston Scientific Corporation recalls Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.

Recall date

November 30, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0938-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.

Why it was recalled

Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body.

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

What was recalled

Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.