Boston Scientific Recalls Emblem MRI S-ICD Pulse Generators Due to Battery Depletion
Boston Scientific is recalling 11,296 Emblem MRI S-ICD pulse generators because accelerated battery depletion may require earlier device replacement.
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: The recall involves a high-risk medical device (S-ICD) where a defect (accelerated battery depletion) poses a risk of harm (loss of device function) but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 11,296 Emblem MRI S-ICD pulse generators, Model A219, which are part of the Boston Scientific S-ICD System. The recall is due to a defect where accelerated battery depletion may result in a need for device replacement earlier than expected.
The affected devices were distributed worldwide. The source text does not specify the number of patients affected or report any injuries or illnesses associated with this defect.
Patients with these devices should contact their healthcare provider or Boston Scientific to discuss the recall and determine if a device replacement is necessary.
The recalled product
- Product
- EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 11,296
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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