FDA-Device2017-01-11Class II
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Boston Scientific Corporation
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.
Sold states
Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
Affected count
15 (2 US; 13 OUS)
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0938-2017Don't want to check this manually?
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