Boston Scientific recalls EMBLEM S-ICD Pulse Generator Model A219 for rare interaction with LATITUDE communicator that may cause temporary S-ICD sensing disablement for 24 hours.
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 A219 devices. The recall is due to a rare interaction with LATITUDE communicators that could temporarily disable the device's sensing function for up to 24 hours.
The EMBLEM S-ICD may temporarily stop sensing heart activity when interacting with LATITUDE communicators. This could last up to 24 hours and might require manual device checks.
People with EMBLEM S-ICDs enrolled in LATITUDE systems. Those most at risk are individuals with heart conditions requiring the device.
Check for EMBLEM S-ICD Pulse Generator Model A219 with GTIN numbers listed. All devices enrolled in LATITUDE systems are affected.
Verify if your EMBLEM S-ICD is enrolled in LATITUDE systems using the provided GTIN numbers.
The recall involves a rare interaction that may temporarily disable the device's sensing function for up to 24 hours.
Check for EMBLEM S-ICD Pulse Generator Model A219 with GTIN numbers listed: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436. All devices enrolled in LATITUDE systems are affected.
Yes, check if your device is enrolled in LATITUDE systems using the GTIN numbers provided.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2442-2023 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2442-2023 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.
