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Boston Scientific Corporation recalls Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Recalled January 11, 2017 · FDA recall Z-0938-2017 · Boston Scientific
Hazard
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. · FDA Class II
Units
15 (2 US; 13 OUS)
Sold at
Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
Description
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.
Product
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →