EMBLEM MRI S-ICD Pulse Generator Recall for Rare Sensing Disablement
Boston Scientific recalls the EMBLEM MRI S-ICD Pulse Generator due to a rare interaction with the LATITUDE communicator that may disable the device's sensing capability for up to 24 hours.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an implanted cardiac device with potential for temporary sensing disablement. No illnesses or injuries have been reported, and the interaction is described as rare and potential, making this a theoretical risk-of-harm scenario that meets the threshold for High severity.
Plain-English summary
Boston Scientific Corporation is recalling the EMBLEM MRI S-ICD Pulse Generator Model A219, a subcutaneous implantable cardioverter-defibrillator (S-ICD). The recall addresses a rare potential interaction between the S-ICD and the LATITUDE communicator device that may cause the S-ICD's sensing function to become disabled for a 24-hour period.
The affected devices were distributed worldwide. Approximately 41,411 units of the EMBLEM S-ICD enrolled in LATITUDE are included in this recall. Patients with an implanted EMBLEM MRI S-ICD should contact Boston Scientific or their healthcare provider for guidance on this recall.
The recalled product
- Product
- EMBLEM MRI S-ICD Pulse Generator Model A219; Subcutaneous Implantable Cardioverter Defibrillator
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 41,411
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- GTIN: 00802526581519
- 00802526584404
- 00802526584411
- 00802526590405
- 00802526590429
- 00802526590436
- All EMBLEM S-ICDs enrolled in LATITUDE
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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