Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Reported: January 11, 2017 Initiated: November 30, 2016 #Z-0938-2017
Product Description
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 15 (2 US; 13 OUS)
- Distribution
- Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.. Recalled by Boston Scientific Corporation. Units affected: 15 (2 US; 13 OUS).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 11, 2017. Severity: Moderate. Recall number: Z-0938-2017.
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