EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

FDA device recall Z-0879-2021 · posted 2021-01-19 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

There is potential for fractures which results in the inability to delivery therapy.

Action taken

Boston Scientific will communicate worldwide to physician customers via a customer letter. The firm notified consignees on December 2, 2020 via customer letter notifications (Dear Healthcare Professional, Dear Healthcare Administrator, and Dear Patient) . The customers notified will be as follows: " EMBLEM Electrode Model 3501 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. " Centers/facilities with EMBLEM Subcutaneous Electrode Model 3501 inventory in stock. 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

Device Design

Status

Terminated

Product code

LWS

Quantity affected

47000 units

Distribution

Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

Date initiated

2020-11-13

Date posted

2021-01-19

Date terminated

2024-07-23

Location

Saint Paul, MN