EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
Recall
- Recall Number
- Z-0879-2021
- Event Number
- 87014
- Firm
- Boston Scientific Corporation
- FEI Number
- 2124215
- Product Code
- LWS
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 13, 2020
- Posted
- January 19, 2021
- Terminated
- July 23, 2024
- Address
- 4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700
Description
EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)
There is potential for fractures which results in the inability to delivery therapy.
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
Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
47000 units