—#202476

Product

EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator

FDA product code: LWS — Implantable Cardioverter Defibrillator (Non-Crt)
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P110042
Affected lot / code info: GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE

Why it was recalled

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 (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 4100 Hamline Ave N, Saint Paul, Minnesota 55112-5700

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2023-07-11
Posted by FDA: 2023-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #202476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.