CLASS II ONGOING Device recall · Reported 30 Aug 2023 · FDA Enforcement Report

Emblem MRI S-icd Pulse Generator recalled by Boston Scientific

Boston Scientific is recalling Emblem MRI S-icd Pulse Generator. The recall was initiated on 11 Jul 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE
Quantity recalled41,411 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2442-2023
FDA event ID
92760
Recalling firm
Boston Scientific, Saint Paul, MN
Classification
Class II
Status
Ongoing
Recall initiated
11 Jul 2023
FDA classified
22 Aug 2023
Reported
30 Aug 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

11 Jul 2023Recall initiated by company
22 Aug 2023Classified by FDA+42 days
30 Aug 2023Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

Worldwide

Questions about this recall

Is Emblem MRI S-icd Pulse Generator recalled?

Yes. Boston Scientific recalled Emblem MRI S-icd Pulse Generator on 11 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-2442-2023.

Why was it 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.

Which lots are affected?

GTIN: 00802526581519, 00802526584404, 00802526584411, 00802526590405, 00802526590429, 00802526590436; All EMBLEM S-ICDs enrolled in LATITUDE

Where was it sold?

Worldwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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