medical Class II Updated 2017-01-11

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

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: IA, NY
Lot/Code Info: Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.
View official government recall

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