FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
- Recall number
- Z-2442-2023
- Recalling firm
- Boston Scientific Corporation
- Product
- EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
- Status
- Open, Classified
- Initiated
- 2023-07-11
- Posted
- 2023-08-22
- Terminated
- not on file
- Reason
- There is a potential for a rare interaction between the EMBLEM S-ICD and LATITUDE communicator, which may cause S-ICD sensing disablement for a 24-hour interval.
- Root cause
- Software design
- Action
- Boston Scientific disseminated an Important Medical Device Information notice to the physician or healthcare professional consignees beginning on 07/11/2023 by hand delivery using their sales representatives, The notices explain the problem, risk, and recommend the following: Please distribute this letter to all HCPs who manage follow-ups of S-ICD patients. Perform the next scheduled device check in-person using a Model 3300 LATITUDE programmer with Model 3877 v1.04 software or Model 3200 EMBLEM programmer with Model 2877 v4.10 software to address any potential for this rare S-ICD behavior. Up-to-date product performance information and a device lookup tool are available within our Product Performance Resource Center at www.bostonscientific.com/ppr. If you have additional questions regarding this information or need to report an adverse event, please contact your Boston Scientific representative or Technical Services, and your local regulatory authority, as applicable. On 08/16/2023 Boston Scientific mailed the letter to EMBLEM S-ICD implanting and/or following physicians/clinics of record. On 09/15/2023, Boston Scientific began distributing a letter dated September 2023 (with the original communication enclosed), to new implanting and following physicians/clinics of record since the August 2023 communication.
- Quantity
- 41,411 units
- Distribution
- Worldwide
- Lot, serial or model codes
- GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE
- 510(k) numbers
- not on file
- PMA numbers
- ["P110042"]
- 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