Recall Z-2442-2023 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Boston Scientific Corporation
EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
| Date | Aug 22, 2023 (initiated Jul 11, 2023) |
| Status | Open, Classified |
| 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. |
| Quantity | 41,411 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.