Boston Scientific Recalls Four VIGILANT X4 CRT-D Devices for Firmware Error
Boston Scientific is recalling four VIGILANT 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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The source text does not report any injuries, illnesses, or fatalities, and the defect is a firmware configuration error rather than a structural failure or contamination.
Plain-English summary
Boston Scientific Corporation is recalling four VIGILANT X4 CRT-D, Model G247, Sterile devices. The recall is due to an incorrect firmware configuration in the devices. These Cardiac Resynchronization Therapy Defibrillators are indicated for patients with heart failure who receive stable optimal pharmacologic therapy and meet specific clinical classifications, such as moderate to severe heart failure with reduced ejection fraction and prolonged QRS duration.
The affected devices have serial numbers 174170, 174349, 174598, and 174606. They were distributed to medical facilities located in Minnesota and Ohio. There was no foreign, government, or military distribution of these units.
Healthcare providers should contact Boston Scientific for instructions on how to address the firmware configuration issue. Patients who have received these devices should consult their healthcare provider for guidance on next steps.
The recalled product
- Product
- VIGILANT X4 CRT-D, Model G247, Sterile. Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 4
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 (4)
- Serial numbers 174170
- 174349
- 174598
- and 174606.
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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