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Recall Observatory FDA recall evidence

Device product

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

Z-0938-2017

November 30, 2016

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 75813
Status
Terminated
Classification
Class II
Quantity
15 (2 US; 13 OUS)
Official record key
device-enforcement:Z-0938-2017

Official wording

Reason: 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.

Code information: 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.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.