Z-0879-2021Class I

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

Name: Z-0879-2021 EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Creator: Boston Scientific Corporation
Published: 2020-11-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-11-13 / Terminated / root cause: design

FDA source

Boston Scientific Corporation began a recall of EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD) on 2020-11-13. FDA classified it as Class I and gives the reason as "There is potential for fractures which results in the inability to delivery therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0879-2021
Classification: Class I
Status: Terminated
Initiated: 2020-11-13
Posted: 2021-01-19
Terminated: 2024-07-23
Recalling firm: Boston Scientific Corporation
Product: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
Reason for recall: There is potential for fractures which results in the inability to delivery therapy.
Root cause tag: design
FDA root cause: Device Design
Action: 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
Quantity in commerce: 47000 units
Distribution: Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Product codes and lots: All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0879-2021	Class I	Terminated	Voluntary: Firm initiated	2021-01-27	2021-01-19

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)