EMBLEM MRI S-ICD Model A219

FDA device recall Z-0951-2021 · posted 2021-02-05 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

Electrical overstress may lead to device malfunction.

Action taken

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

Status

Terminated

Product code

LWS

Quantity affected

872 units

Distribution

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

Date initiated

2020-12-02

Date posted

2021-02-05

Date terminated

2022-06-23

Location

Saint Paul, MN