FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
- Recall number
- Z-0879-2021
- Recalling firm
- Boston Scientific Corporation
- Product
- EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
- Status
- Terminated
- Initiated
- 2020-11-13
- Posted
- 2021-01-19
- Terminated
- 2024-07-23
- Reason
- There is potential for fractures which results in the inability to delivery therapy.
- 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
- 47000 units
- Distribution
- Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
- Lot, serial or model codes
- All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.
- 510(k) numbers
- not on file
- PMA numbers
- ["P110042S077"]
- Product code
- LWS
- Firm FEI
- 2124215
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28