Boston Scientific Recalls Five Resonate EL ICD VR Devices for Firmware Error
Boston Scientific is recalling five Resonate EL ICD VR devices due to incorrect firmware configuration. The devices were distributed to medical facilities in Minnesota and Ohio.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The source text does not report any illnesses, injuries, or deaths, and the defect is a firmware configuration error rather than a structural failure or contamination.
Plain-English summary
Boston Scientific Corporation is recalling five units of the Resonate EL ICD VR, Model D432, sterile implantable cardioverter-defibrillators. The recall is being conducted because the devices have an incorrect firmware configuration.
The affected devices, identified by serial numbers 224020, 224209, 224322, 224366, and 224506, were distributed to medical facilities located in Minnesota and Ohio. There was no distribution to foreign, government, or military entities.
Healthcare providers and patients should contact Boston Scientific Corporation for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- RESONATE EL ICD VR, Model D432, Sterile.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 5
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 (5)
- Serial numbers 224020
- 224209
- 224322
- 224366
- and 224506
Distribution
Part of a larger recall action
This product is one of 5 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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