Recalls / —

—#185041

Product

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

FDA product code

LWS — Implantable Cardioverter Defibrillator (Non-Crt)

Device class

Class 3

Medical specialty

Unknown

PMA numbers

P110042S077

Affected lot / code info

All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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

Recalling firm

Firm

Boston Scientific Corporation

Address

4100 Hamline Ave N, Bldg 3, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern

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

Timeline

Recall initiated

2020-11-13

Posted by FDA

2021-01-19

Terminated

2024-07-23

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #185041. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.