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Terminated

EMBLEM S-ICD Model A209

FDA Recall Z-0950-2021 · Posted 2021-02-05

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeLWS
Date Initiated2020-12-02
Date Terminated2022-06-23
Product Quantity1953 units

Reason for Recall

Electrical overstress may lead to device malfunction.

Firm Action

Boston Scientific will communicate worldwide to physician customers via a customer letter. The customers notified will be as follows: " EMBLEM S-ICD implanting physicians/centers and/or following physicians/centers of record for the advisory population. Physicians associated with an advisory device will receive a list of affected model/serials for patients which they have implanted and/or followed or sent to their center. Boston Scientific will deliver the notification by hand or email via our sales representatives or deliver the letter via Federal Express, Courier, or email. Boston Scientific will reconcile that 100% of the identified customers /customer representatives signed for the letter, or the letter has been confirmed to be delivered. Boston Scientific will post the product advisory letter on our website, within the Product Performance Resource Center located @ www.bostonscientific.com/en-US/pprc/productadvisories.html

Root Cause

Process control

Distribution Pattern

Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.

Official Source

View FDA Recall →

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

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