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

FDA device recall Z-2442-2023 · posted 2023-08-22 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

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.

Root cause

Software design

Status

Open, Classified

Product code

LWS

Quantity affected

41,411 units

Distribution

Worldwide

Date initiated

2023-07-11

Date posted

2023-08-22

Location

Saint Paul, MN