Boston Scientific Recalls 11 Resonate X4 CRT-D Devices for Firmware Error
Boston Scientific is recalling 11 Resonate X4 CRT-D 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, and the source text does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Boston Scientific Corporation is recalling 11 units of the Resonate X4 CRT-D, Model G447, Sterile. The recall is due to an incorrect firmware configuration in the devices.
The affected devices were distributed to medical facilities located in Minnesota and Ohio. There was no foreign, government, or military distribution. The specific serial numbers involved are 174030, 174900, 174995, 175178, 175328, 175329, 175396, 175440, 175503, 175545, and 175606.
Medical facilities should contact Boston Scientific for further instructions regarding the recall and replacement or repair of the affected devices.
The recalled product
- Product
- RESONATE X4 CRT-D, Model G447, Sterile.
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 11
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 (11)
- Serial numbers 174030
- 174900
- 174995
- 175178
- 175328
- 175329
- 175396
- 175440
- 175503
- 175545
- and 175606
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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