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Terminated

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

FDA Recall Z-0938-2017 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWP
Date Initiated2016-11-30
Date Terminated2017-12-13
Product Quantity15 (2 US; 13 OUS)

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.

Firm Action

Boston Scientific sent an "Important Medical Device Information" letter dated November 30, 2016. The letter was addressed to "Dear Doctor". The letter described the problem and the product involved in the recall. The letter also described the "Clinical Considerations, Recommendations, Affected Population & Further Information". For questions contact your local Boston Scientific representative or Technical Services. For further questions, please call ( 651) 582-4000.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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