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Open, Classified

EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

FDA Recall Z-0936-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeLWS
Date Initiated2020-12-02
Product Quantity11296 units

Reason for Recall

Accelerated battery depletion may result in a need for device replacement earlier than expected.

Firm Action

The firm issued an Important Medical Device Advisory beginning on 12/02/2020 to its field representatives and implanting surgeons by letter; The notice explained the issue and provided recommendations for the surgeons and referred the surgeons with additional questions, or to report a clinical event, to their Boston Scientific representative or Technical Services. Patients were also notified of the issue and provided them with the website and instructions on how to confirm whether his/her implant was part of the affected groups.

Root Cause

Process change control

Distribution Pattern

worldwide

Official Source

View FDA Recall →

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

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