Device product
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Z-0938-2017
Product summary
- 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
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.