Boston Scientific recalls EMBLEM S-ICD Pulse Generator Model A209 for rare interaction with LATITUDE communicator that may cause temporary S-ICD sensing disablement. Affected units have specific GTINs and are enrolled in LATITUDE.
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.
Boston Scientific is recalling EMBLEM S-ICD Pulse Generator Model A209 devices due to a rare interaction with LATITUDE communicators that could temporarily disable the device's sensing function. This may require medical attention if the device fails to sense heart rhythms properly.
The EMBLEM S-ICD may temporarily stop sensing heart rhythms when interacting with LATITUDE communicators. This could lead to missed heart rhythm detection and require medical intervention if the device fails to respond appropriately.
People with EMBLEM S-ICD Pulse Generator Model A209 devices enrolled in LATITUDE are affected. Those with the device and LATITUDE communication are most at risk.
Check for the EMBLEM S-ICD Pulse Generator Model A209 with specific GTIN numbers listed in the recall. Devices enrolled in LATITUDE communication systems are also affected.
Verify if your EMBLEM S-ICD is enrolled in LATITUDE communication systems using the device's model and GTIN numbers provided in the recall.
The recall describes a rare interaction that may temporarily disable the device's sensing function, but it is not expected to cause serious injury. Boston Scientific considers this low risk.
Check the GTIN numbers listed in the recall or confirm if your EMBLEM S-ICD is enrolled in LATITUDE communication systems.
The recall does not specify a remedy, so no action is required beyond checking if your device is affected and enrolled in LATITUDE.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2441-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2441-2023 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
