Boston Scientific Recalls Emblem S-ICD Pulse Generators Due to Battery Depletion
Boston Scientific is recalling 7,093 Emblem 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: This is an FDA Class II recall for a medical device where the hazard (accelerated battery depletion) poses a risk of harm (loss of device function) but the source text does not report any injuries, illnesses, or deaths.
Plain-English summary
Boston Scientific Corporation is recalling 7,093 Emblem S-ICD pulse generators, Model A209, as part of the Boston Scientific S-ICD System. The recall is due to accelerated battery depletion, which may result in a need for device replacement earlier than expected.
The affected devices were distributed worldwide. The source text lists specific serial numbers for units distributed in the US, ranging from 101624 to 111685.
Consumers with this device should contact their healthcare provider or Boston Scientific for instructions on monitoring the device and scheduling potential replacement.
The recalled product
- Product
- EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 7,093
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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